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MedWatch - Stryker Custom Cranial Implant Kits: Class 1 recall due to lack of assurance of sterility and risk on infection
Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. Custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. Implanting surgeons were notified individually of the problem in a October 24, 2008 recall letter. The letter advised them of the risk for serious infections, and instructed them to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits.
Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Stryker
NEW! MedWatch - Hydromorphone tablets [ETHEX] recalled due to oversided tablets and potential for over dosage
ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. Hydromorphone is a drug used for pain management. If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation. The recalled tablets are a blue, round tablet with a script "E" on one side and a "2" on the other side.
The parent company of ETHEX Corporation, KV Pharmaceutical has advised FDA that it is voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management's attention.
Read the complete MedWatch 2008 Safety summary, including links to the Ethex and KV press releases and a list of KV products affected by the suspension, at: http://www.fda.gov/medwatch/...safety08.htm#Hydromorphone
FDA MedWatch - Weight Loss Pills contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk
FDA alerted consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. The undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant ( a drug not approved for marketing in the United States), phenytoin ( an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). The weight loss products, some of which are marked as "dietary supplements," are promoted and sold on various web sites and in some retail stores.
FDA advises consumers who use the products to stop taking them and consult their healthcare professional immediately as the health risks posed by these products can be serious (for example, high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke). FDA also encourages consumers to seek guidance from healthcare professional before purchasing weight loss products. See the FDA News Release for a listing of the names of the 25 referenced products.
Read the MedWatch 2008 safety summary, including links to the News Release and Questions and Answers, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Weight
MedWatch - SunMed Greenline/D MacIntosh No. 3 Laryngoscope Blades recalled due to potential to break during use
Sun Med and FDA notified healthcare professionals of the Class 1 recall of Greenline/D MacIntosh No. 3 Laryngoscope Blades. This product is a part of a medical device [laryngoscope] used to view the vocal cords and other structures when opening a patient's airway. A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure. This device was distributed from January 16, 2007 through April 13, 2007. The company sent a notice to their distributors requesting that the product be returned.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA/CDRH recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#GreenlineD
FDA Teams With WebMD For New Online Consumer Health Information
FDA MedWatch - Gravity Compensating Accessory by Integra NeuroSciences: recalled because devices may leak cerebrospinal fluid
Integra NeuroSciences and FDA notified healthcare professionals of a recall of the Gravity Compensating Accessory (GCA), manufactured in January, 2008 through May, 2008 and distributed from February 22, 2008, through June 1, 2008. The GCA is part of a system that redirects (shunts) excess fluid from the brain to the abdomen. The GCA prevents too much fluid from being redirected from the brain while sitting or standing. The recalled devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system. Patients should contact their healthcare professional with any questions or concerns.
Read the MedWatch 2008 safety summary, including a link to the recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#GCA
FDA MedWatch - Healon D Ophthalmic Viscosurgical Device: recall due to syringes with endotoxin levels above the required limit
Advanced Medical Optics (AMO), Inc. and FDA notified healthcare professionals of a recall of Healon D Ophthalmic Viscosurgical Device, Lot Number UD30654, 30 mg/mL fill size syringes. Some of the tested OVD syringes had endotoxin levels above the required limit. These higher levels may cause intraocular inflammation and/or Toxic Anterior Segment Syndrome in patients following surgery. Healthcare professionals should stop using and remove from their inventory all units of the affected lot and contact AMO at 1-877-266-4543.
Read the MedWatch 2008 safety summary, including a link to the recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Healon
FDA MedWatch - Oral Sodium Phosphate (OSP) Products for Bowel Cleansing: reports of acute phosphate nephropathy, Boxed Warning to be added to labeling
FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury.
FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products. FDA recommends, in light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional.
Read the MedWatch 2008 safety summary, including a link to the FDA Drug Information Page, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#OSP
NEW! FDA MedWatch - 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP: Recall of one lot due to possible incorrect bar code for 5% Dextrose Injection, USP
Hospira, Inc. notified healthcare professionals of a recall of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers. A small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion. The affected lot was shipped to U.S. customers between July 2008 and September 2008. Healthcare facilities with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it.
Read the MedWatch 2008 safety summary, including a link to the company's press release, at: http://www.fda.gov/medwatch/...safety08.htm#20meqPotChlor
NEW! MedWatch - Innohep (tinzaparin): Clinical study stopped early because of interim finding of increased all-cause mortality in patients who received drug
FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study's Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.
In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep
NEW! FDA MedWatch-Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae- Recalled due to reports of difficulty retracting the introducer from the cannula
Terumo Cardiovascular Systems notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes (see Terumo press release for complete list). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death. Healthcare professionals are advised to not use the product unless medically necessary. In those cases, the cannula should be used without the introducer.
Read the MedWatch 2008 safety summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tenderflow
NEW! FDA MedWatch - The December 2008 Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch e-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
NEW! FDA MedWatch - Zhen De Shou Fat Loss Capsules recalled due to undeclared drug, sibutramine which may cause significant increase in blood pressure
Fashion Sanctuary announced a recall of Zhen De Shou Fat Loss Capsules because FDA analysis found the product to contain undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The product was primarily distributed in the U.S and sold via the Internet and the recall affects all lot codes and use by dates. Consumers who may have purchased product from this company should immediately discontinue using the product. Read the complete MedWatch Safety summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Zhen
NEW! MedWatch - Starcaps Dietary Supplement Capsules - Recall due to undeclared drug, Bumetanide, resulting in drug interactions, hypotension
Balanced Health Products, Inc. announced a recall of STARCAPS due to the presence of an undeclared drug ingredient, Bumetanide. Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide. Consumers who have this product should immediately discontinue taking it and return the product to the manufacturer. See the company's press release for specific lot number information. Read the complete MedWatch 2008 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Starcaps
NEW! FDA MedWatch - Phenytoin and Fosphenytoin Sodium associated with potential increased risk of serious skin reactions
FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided in the MedWatch safety alert. Read the MedWatch safety summary, including links to the Information for Healthcare Professionals and FDA Drug Information pages, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Phenytoin
NEW! MedWatch - Animas Insulin Pumps: Battery Caps - Class 1 recall due to inadvertent device resetting, risk of hyperglycemia
Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump. The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008. There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia). Healthcare professionals are advised to ensure that their patients replace the battery cap on their insulin pump. Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 Recall Notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#batterycap
NEW! FDA MedWatch: Benzoyl Peroxide Acne Cream 10%: Product Recalled Because Samples Contained Burkholderia Cepacia Bacteria
CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. The products were recalled because samples of the products were found to contain bacteria, Burkholderia Cepacia, formerly known as Pseudomonas Cepacia. There may be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems. Consumers should discontinue using the product and should return it to the place of purchase. See the company's press release for photos of product packaging. Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall press release at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Benzoyl
EW! FDA MedWatch- Bisphosphonates-Update To The Early Communication Issued Regarding Atrial Fibrillation With Bisphosphonates
FDA issued an update about the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget's disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication. Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Update of Safety Review Follow-up to the October 1, 2007, Early Communication about the Ongoing Safety Review of Bisphosphonates, regarding this issue at: http://www.fda.gov/medwatch/...safety08.htm#bisphosphonates2
NEW! FDA MedWatch- FDA MedWatch- Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)- Product Recalled Due To Possible Metal Fragments In The Bottle
Johnson & Johnson- Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of Infants' Mylicon Gas Relief Dye Free Drops ( Lot No. SMF007 and SMF008) sold in 1 oz plastic bottles that were distributed after October 5, 2008, nationwide. The product was recalled because some bottles could include metal fragments that were generated during the manufacturing process. Parents who have given the product to their infant and are concerned should contact their healthcare professional. Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#mylicon
NEW! FDA MedWatch- FDA MedWatch- Propafenone HCl, Isosorbide Mononitrate Extended Release, Morphine Sulfate Immediate and Extended Release, Dextroamphetamine Sulfate- Products Recalled Due To The Potential For Oversized Tablets
Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets). The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences. Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's recall notice for specific lot numbers of the products affected by this recall. Read the entire MedWatch 2008 Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ethex
FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.
DEA announces that on Tuesday, October 28, 2008, an updated electronic version of the DEA form 106 will be available through the Diversion website
This newer version requires the registrant to include the National Drug Code (NDC) which will help to accurately track controlled substances reported as stolen or lost.
The attached letter will be posted on the Diversion website advising all DEA registrants of this change in reporting requirements. DEA will notify any registrant that submits a paper copy of the obsolete DEA form 106 after October 28, 2008, to discontinue using this form. DEA advises registrants wishing to obtain an electronic copy of the new DEA form 106 to go DEA's website and select the icon "DEA Form 106 Online, Report Theft or Loss of Controlled Substances."
Although the paper version is still available, DEA encourages registrants to use the updated electronic version. A registrant can still receive a paper copy of the updated form by writing to DEA Headquarters, Attn: Registration/ODR, P.O. Box 2639, Springfield, VA 22152. PLEASE NOTE: The correct phone number for the DEA Registration & Program Support Section is: (202) 307-4925. The letter on the DEA website will be corrected to reflect this as well.
Destruction and Disposal of Prescription Drugs
Below are links to external websites which contain guidance on how to destroy or dispose of controlled substances.
Florida Department of Environmental Protection: How to Dispose of Unwanted Medications
Office of National Drug Control Policy: Proper Disposal of Prescription Drugs
U.S. Food and Drug Administration: How to Dispose of Unused Medications
U.S. Drug Enforcement Administration: Pharmacist's Manual (Sees page 12-14)
FDA MedWatch - September 2008 Drug Safety-Related Labeling Changes for 36 Drugs Now Available on Web
The September 2008 posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERTS, and MEDICATION GUIDES. The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/safety/2008/sep08_quickview.htm
FDA MedWatch- Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator- Class I Recall Because Of Unsupported Claims
FDA notified healthcare professionals of a Class I Recall of the Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. The manufacturer has submitted no evidence to FDA to support any of their claims that the product could treat or cure such diseases as cancer, depression, infection and pain. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device. Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Recall notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Vibe
FDA MedWatch - The November 2008 Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
FDA Issues Final Rule Requiring Toll-Free Number on Medication Labeling
Food and Drug Administration (FDA) has issued a final rule requiring the labeling for certain medications to include a toll-free number for patients to report side effects. The final rule confirms the interim final rule ?Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products? and its requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act. The statement must include a toll-free number and advise that the number is to be used only for reporting side effects and is not intended for medical advice. This final rule also affirms the interim final rule?s addition of a new part 209 to the regulations requiring distribution of the side effects statement. This final rule implements provisions of the Best Pharmaceuticals for Children Act (Public Law 107-109) and the Food and Dug Administration Amendments Act of 2007. The final rule is effective November 28, 2008, and the compliance date is July 1, 2009. More information is available in the Federal Register [Docket No. FDA-2003-N-0313 ].
FDA Creates Web Page with Medication Safety Information for Patients, Professionals
Patients and health care professionals can now go to a single page on the Food and Drug Administration (FDA) Web site to find a wide variety of safety information about prescription medications. The Web page provides links to information on drug labeling; drugs that have a Risk Evaluation and Mitigation Strategy to ensure that their benefits outweigh their risks; post-market studies of drugs? safety, efficacy, or optimal use; clinical trials; drug-specific safety information; warning letters; and consumer articles. Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007 and is among FDA's efforts to address the safe use of medications throughout their lifecycle. FDA recently launched another Web page that provides information on risks involved in using unapproved drugs. The new page has sections tailored to the interests of health care professionals, patients, and industry audiences, as well as links to general information for all audiences.
Methamphetamine Production Prevention Act of 2008 Signed into Law
President Bush signed into law Senate (S) Bill 1276, the Methamphetamine Production Prevention Act of 2008, on October 14, 2008. Now known as Public Law No. 110-415, the legislation revises the logbook requirements of the federal Combat Methamphetamine Epidemic Act, enacted in 2006, which limits the amount of methamphetamine precursor drugs, such as pseudoephedrine, that a patient can buy and requires pharmacies to keep written or electronic logbooks recording each purchase of the drugs. The new law changes the earlier act to facilitate the use of electronic logbooks instead of written logbooks and provides grants to accomplish this goal. The new system is intended to provide law enforcement with easier access to information and streamline recordkeeping requirements for pharmacies.
President Bush Signs Ryan Haight Act, Cracks Down on Internet Drug Outlets
President Bush signed into law House of Representatives (HR) Bill 6353, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 on October 15, 2008. Now known as Public Law No. 110-425, the new law amends the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. The law defines "valid prescription" as one issued for a legitimate purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient. The legislation also adds definitions to the Controlled Substances Act relating to online pharmacies and the issuance of prescriptions over the Internet, imposes registration and reporting requirements on online pharmacies, and increases criminal penalties involving Schedule III, IV, and V controlled substances. The law also authorizes states to apply for injunctions or obtain damages and other civil remedies against online pharmacies that are deemed a threat to state residents.
FDA MedWatch- Thoratec HeartMate II Left Ventricular Assist System- Device Correction: Wear And Fatigue Of The Percutaneous Lead Connecting The Blood Pump With The System Controller May Cause Serious Injury Or Death
Thoratec Corporation notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having Catalogue No. 1355 or 102139), distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding the above issue. http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeartMate
FDA MedWatch: Transvaginal Placement of Surgical Mesh- Serious Complications Associated With Transvaginal Placement Of Surgical Mesh In Repair of Pelvic Organ Prolapse And Stress Urinary Incontinence
FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mesh
MedWatch - Raptiva (efalizumab): Boxed Warning describes risk for life-threatening infections
FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age.
Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug.
Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva. Read the complete MedWatch 2008 Safety summary, including links to the FDA press release and the revised prescribing information, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Raptiva
FDA MedWatch- Dextroamphetamine Sulfate 5mg Tablets- Drug Recall Due To The Potential For Oversized Tablets
Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at: http://www.fda.gov/medwatch/...safety08.htm#Dextroamphetamine
FDA MedWatch - Tiotropium (Spiriva): updated information on risk of stroke and reports of cardiovascular adverse outcomes
FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo.
Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.
FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.
Read the complete MedWatch 2008 Safety summary, including a link both todays update and the original March 18th Early Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium
FDA MedWatch- OTC Cough and Cold Medicines- Product Labels Being Modified To State " Do Not Use" In Children Under 4 Years Of Age
FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.
Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Press Release regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#CoughCold
FDA MedWatch- Nebion HLX-8 Magnetic Resonance Device: Device Not Approved By FDA
FDA notified healthcare professionals of a Class I Recall of the Nebion HLX-8 Magnetic Resonance Device. The manufacturer of the device made unsupported claims that the product could be used to treat many different medical conditions and diseases such as cancer (including breast, bone, lung, and pancreatic), carpel tunnel syndrome, migraines, premenstrual syndrome, rheumatoid arthritis, ruptured disks, shingles, and sports injuries and sprains. The device was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device.
Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Class I Recall notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Nebion
FDA MedWatch- Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit- Class I Recall
Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#INDURA
FDA MedWatch -Mobile Oxygen Storage Tank- Class I Recall Because The Device's Pressure Gauge May Rupture And May Catch Fire
Pacific Consolidated Industries, LLC, and FDA notified healthcare professionals of the Class I Recall of the Mobile Oxygen Storage Tank manufactured and distributed between January - March 2007, because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. The mobile oxygen storage tank is used in military aircraft for treating wounded patients and in disaster areas to quickly supply oxygen to patients. Facilities with the Mobile Oxygen Storage Tank should keep the device in quarantine until arrangements are made to ship the device back to the manufacturer.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Recall Notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Pacific
FDA MedWatch - The September 2008 FDA Patient Safety News is now available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. This special edition repeats some of the most important safety issues that continue to pose a public health problem. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
MedWatch - Tumor necrosis factor-alpha blockers: delays in diagnosis of fungal and other opportunistic infections
Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals
FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-a blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified.
MedWatch - Disposable Battery Operated Lavage System: risk of explosion and harm to patients and staff
FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems' (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursing units. The cutting of the battery pack's cable can lead to a short circuit, causing the batteries to discharge rapidly, producing intense heat and flammable gases with a resulting explosion that expels flammable gases and toxic chemicals endangering both patients and staff. Recommendations for avoiding this risk are provided in the medical device safety alert.
Read the complete MedWatch 2008 Safety summary, including a link to the Medical Device Safety alert, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#BOLSFDA MedWatch- Rituzan (rituximab)- Important New Safety Information Regarding Progressive Multifocal Leukoencephalopathy With The Use Of Rituxan
Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and updated prescribing information for Rituxan regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#RituxanFDA MedWatch- LifePak CR Plus Automated External Defibrillators- Class I Recall Because The Shock Button Is Not Visible Which Impedes Responder's Ability To Provide Shock Therapy
Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Recall Notice regarding this issue: http://www.fda.gov/medwatch/safety/2008/safety08.htm#LifePakCRFDA MedWatch -Infant Formula Manufactured in China: Health Information Advisory Due To Reports Of Possible Contamination With Melamine/p>
FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formula have fulfilled the requirements to sell this product in the United States. FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Caregivers should not feed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formula manufactured in the United States. Individuals should contact their health care professional if they have questions regarding their infant's health or if they note changes in their infant's health status.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Health Information Advisory regarding the above issue: http://www.fda.gov/medwatch/safety/2008/safety08.htm#formulaChinaIntra-articular Use In Children
Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32.!
Read the entire 2008 MedWatch Safety Summaries, including a link to the manufacturer's Dear Healthcare Provider Letter and the revised prescribing information for Phosphocol P 32 at http://www.fda.gov/medwatch/safety/2008/safety08.htm#PhosphocolFDA MedWatch- FDA Drug Safety Newsletter- Summer 2008 Edition Available For Healthcare Professionals And The Medical Community/p>
The Drug Safety Newsletter is a FDA publication for healthcare professionals and the medical community. The newsletter provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research. The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals.
Read the entire MedWatch 2008 Safety Summary, including a link to the FDA Drug Safety Newsletter at: http://www.fda.gov/cder/dsn/2008_summer/toc.htmFDA MedWatch - Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% - Particulate matter detected in product
Ucyclyd Pharma, Inc. informed healthcare professionals of the detection of particulate matter in the Ammonul Injection product. This particulate matter may impact the safe use of Ammonul. To ensure optimal patient care, healthcare providers are being instructed to use a MilIex Durapore GV 33 mm Sterile Syringe Filter (0.22 µm ) during the admixture process when injecting Ammonul into the 10% Dextrose IV bag. Since this particulate matter may not be readily seen on visual inspection, a filter must be employed in all cases regardless of whether particulate matter is seen in the vial. Testing has confirmed the removal of this specific particulate when using this filter to admix Ammonul. Contact Ucyclyd Pharma, 1-888-829-2593, or 1-800-900-6389 -- a representative is available 24 hours, seven days a week.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Provider Letter, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ammonul
FDA MedWatch - Tarceva (erlotinib) - Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva
OSI and Genentech notified healthcare professionals that cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Patients with hepatic impairment receiving Tarceva should be closely monitored during therapy and the product should be used with extra caution in patients with total bilirubin >3x ULN. Dosing should be interrupted or discontinued if changes in liver function are severe, such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside the normal range. New information from a pharmacokinetic study in patients with moderate hepatic impairment associated with significant liver tumor burden has been provided in the revised prescribing information, and other recommendations are included in the WARNINGS and DOSAGE AND ADMINISTRATION sections.
Read the entire 2008 MedWatch Safety Summary, including links to the manufacturer's Dear Healthcare Provider Letter and the revised prescribing information for Tarceva, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tarceva
FDA MedWatch - Epoetin alfa- Preliminary Safety Findings Show More Deaths In Patients Given Epoetin-alpha Versus Placebo
FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.
FDA anticipates the receipt of additional data within the next several weeks. As soon as the review of these data is complete, FDA will communicate our conclusions and recommendations to the public. The finding of increased mortality in patients receiving epoetin alfa in the German trial suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About An Ongoing Safety Review regarding this issue: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA3
FDA MedWatch - Statin drugs and risk of amyotrophic lateral sclerosis (ALS)
An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The FDA analysis, undertaken after the agency received a higher than expected number of reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.
The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use. Results from this study should be available within 6-9 months. FDA is also examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.
Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA New Release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Statin
FDA MedWatch - The October 2008 FDA Patient Safety News Video is now available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
FDA Issues Health Information Advisory on Infant Formula
In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.
The FDA is advising caregivers not to feed infant formula manufactured in China to infants. This should be replaced with an appropriate infant formula manufactured in the United States as mentioned below. Individuals should contact their health care professional if they have questions regarding their infant's health or if they note changes in their infant's health status.
The FDA began investigating the reports of contamination immediately and received information from the companies who manufacture infant formula for the American market that they are not importing infant formula or source materials from China. The following manufacturers have met the necessary FDA requirements for marketing milk-based infant formulas in the United States: Abbott Nutritionals, Mead Johnson Nutritionals, Nestle USA, PBM Nutritionals, and Solus Products LLC. Also, one manufacturer, SHS/Nutricia, Liverpool, England, markets an amino acid based exempt infant formula that does not contain any milk-derived ingredients.
We are asking state officials to work with the Agency to assist with the removal of any Chinese infant formula found on store shelves, and to warn members of the Asian community to avoid using Chinese manufactured infant formula.
It has been reported that a number of infants in China who have consumed Chinese manufactured infant formula are suffering from kidney stones, a condition which is rare in infants. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can causes kidney diseases such as those seen in these Chinese infants.
FDA requires that all infant formula manufacturers register with the Agency and adhere to specific labeling and nutritional requirements. All properly registered infant formula manufacturers marketing infant formula in the United States undergo an annual inspection of their production facilities.
Governor Crist issues >Executive Order 08-187, September 5, 2008 regarding Emergency Management for Hurricane Ike
Governor Crist issued Executive Order 08-187 , declaring a state of emergency for the entire State of Florida due to the threat that Hurricane Ike imposes to the state
Section 4, paragraph D, of the executive order authorizes pharmacists in areas or counties covered under this executive order to dispense up to a 30-day emergency prescription refill in accordance with section 465.0275, Florida Statutes.
Further, section 8, of the executive order provides that medical professionals and workers, social workers, and counselors with good and valid professional licenses issued by states other than the State of Florida may render such services in Florida during this emergency for persons affected by this emergency with the condition that such services be rendered to such persons free of charge, and with the further condition that such services be rendered under the auspices of the America Red Cross or the Florida Department of Health.
Additionally, please note that section 252.358, Florida Statutes, requires that all health insurers, managed care organizations, and other entities that are licensed by the Office of Insurance Regulation and provide prescription medication coverage as part of a policy or contract waive time restrictions on prescription medication refills, which include suspension of electronic "refill too soon" edits to pharmacies, to enable insureds or subscribers to refill prescriptions in advance, if there are authorized refills remaining, and shall authorize payment to pharmacies for at least a 30-day supply of any prescription medication, regardless of the date upon which the prescription had most recently been filled by a pharmacist, when the following conditions occur: The person seeking the prescription medication refill resides in a county that is under a hurricane warning issued by the National Weather Service, is declared to be under a state of emergency in an executive order issued by the Governor, or has activated its emergency operations center and its emergency management plan.
DOH PRESS RELEASE: Medications in Disaster Situations
TALLAHASSEE In the event of a tropical storm or hurricane, you may need to evacuate your home and regular services may be temporarily limited. To ensure that you are able to continue taking your medications under such circumstances, the Florida Department of Health (DOH) recommends that you plan now by taking the following measures:
Call your doctor now and request a 30-day supply of medication if possible.
Get a pill organizer and pack enough pills for two weeks. Get assistance from your caregiver or medical professional in making sure you have packed enough of the medications you will need.
Make a list of all your medications: how they should be taken, what time, etc. Make copies of the list. Put one copy with the medications; give one to a friend, and keep one with you at all times. Make sure to list any allergies, as well as foods you need to avoid. Your doctor's name and emergency phone number should also be on this list. Your medical professional or caregiver should be able to assist you in this.
Pack your medications now to have ready to carry with you at a moment's notice.
If you are taking prescription narcotic pain medications, keep them with you at all times.
If you are on a special diet or require special supplements, take a two-week supply with you.
Over the counter items that you should also bring with you: Pain reliever/ Ibuprofen, antacid, laxative/suppository, Imodium, Benadryl, decongestant, antibiotic ointment, lubricating eye drops.
If you are using respiratory medications with a nebulizer, bring it with you.
FDA MedWatch- Boston Scientific NexStent Monorail-Class I Recall Because The Tip Of The Stent May Detach From The Delivery System During Carotid Artery Stenting Procedures
Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. This recall does not affect stents that have already been implanted. Patients should contact their healthcare professional if they have any questions.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#NexStent
FDA MedWatch - Byetta (exenatide) - Reports of 6 cases of hemorrhagic or necrotizing pancreatitis since October 2007
Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis. Read the complete MedWatch 2008 Safety Summary, including a link to the '"Information for Healthcare Professionals" page, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta
FDA MedWatch-Tysabri (natalizumab)-Two New Cases Of Progressive Multifocal Leukoencephalopathy In European Patients Receiving Drug As Monotherapy For Multiple Sclerosis For More Than One Year
FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year. PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies. Approximately 39,000 patients have received treatment with Tysabri worldwide, with approximately 12,000 patients receiving treatment for a least one year. No new cases have been seen in the US, where about 7,5000 patients have received the drug for greater than one year and approximately 3,300 patients have received the drug for at least one and one-half years. In the U.S., Tysabri is available only to patients with relapsing multiple sclerosis or Chron's disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under this program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications. Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy. Healthcare professionals should continue to monitor patients for sign and symptoms of PML. Additionally, Tysabri should not be infused if PML is suspected.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Information for Healthcare Professionals Sheet regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri2
FDA MedWatch- Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) - Report Of SEAS Trial Of A Possible Association Between The Use Of Vytorin And A Potential Increased Incidence Of Cancer
FDA informed healthcare professionals that the Agency is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytorin and a potentially increased incidence of cancer. Vytorin is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events. Recently, FDA obtained preliminary results from the SEAS trial. The clinical trial tested whether lowering LDL-cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. A lower overall cardiovascular risk was not found with Vytorin. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with and died from all types of cancer combined when compared to placebo during the 5-year study.
FDA anticipates receiving a final SEAS study report in about 3 months and the Agency's review and evaluation of the clinical trial data and other relevant information should take approximately 6 months. FDA will communicate its conclusions and recommendations at that time. Healthcare professionals and caregivers should continue to monitor patients taking Vytorin and report side effects from the use of this drug to the Agency.
Read the complete MedWatch 2008 Safety Summary, including a link to the '"Early Communication About an Ongoing Safety Review of Ezetimibe/Simvastatin (marketed as Vytorin); Simvastatin (marketed as Zocor); and Ezetimibe (marketed as Zetia)", at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ezetimibe2
FDA MedWatch -Vivitrol (naltrexone)- Serious Injection Site Reactions May Occur
FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.
Read the entire MedWatch Safety Summary, including a link to the FDA Drug Information Page regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#naltrexone
FDA MedWatch - Simvastatin Used With Amiodarone - Risk of rhabdomyolysis when simvastatin is used with amiodarone
FDA notified healthcare professionals of the risk of muscle injury, rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. Although a revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily, FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.
Read the complete MedWatch safety summary, including links to the FDA Drug Information page, Information for Healthcare Professionals sheet, and labels (Prescribing Information) for simvastatin and amiodarone products, at http://www.fda.gov/medwatch/safety/2008/safety08.htm#Simvastatin
FDA MedWatch -The August 2008 FDA Patient Safety News Video is now available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn
MedWatch - Levitronix CentriMag Extracorporeal Blood Pumping System: risk of pump stoppage with use of certain electrosurgery units
Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. The Blood Pumping System is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure. A July 24, 2008 Levitronix device correction letter informed physicians not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because use may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.
Read the complete MedWatch 2008 Safety summary, including links to the FDA recall notice and the Levitronix Dear Doctor letter, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#CentriMag
FDA MedWatch -Viapro 375mg Capsules- Voluntary Recall Because The Product Was Found To Contain A Potentially Harmful Analog Of Sildenafil
EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro.
Read the entire 2008 MedWatch Safety summary, including a link to the manufacturer's Press Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Viapro
FDA MedWatch- Erythropoiesis Stimulating Agents: Procrit, Epogen, and Aranesp- FDA Clarifies Approved Conditions For Use Of ESAs In Patients With Cancer And Revises Dosing Directions
Amgen and FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Follow Up to an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA2
MedWatch - Mitoxantone (marketed as Novantrone and generics): updated cardiotoxicity warnings/recommendations
FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug. These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS.
Read the complete MedWatch 2008 Safety summary, including links to the Information for Healthcare Professionals sheet and the previous 2005 safety alert, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mitoxantrone
MedWatch - Abacavir/Ziagen: Association between HLA allele and severe hypersensitivity reactions identified
FDA informed healthcare professionals that serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. FDA reviewed data from two studies that support a recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Development of clinically suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701.
Read the complete MedWatch 2008 Safety Summary, including a link to the Information for Healthcare Professionals document, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Abacavir
MedWatch - Micro-bubble Contrast Agents (Definity, Optison): changes to Boxed Warnings, Warnings and Contraindications
FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
These changes reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.
Read the complete MedWatch 2008 safety summary, including links to the Information for Healthcare Professionals and previous MedWatch alerts, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Microbubble
FDA MedWatch -Electronic Medical Devices- Possible Malfunction Caused By Computed Tomography (CT) Scanning
FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding this issue at: http://www.fda.gov/medwatch/...safety08.htm#ElectronicMedical
FDA MedWatch- MedWatch-Sodium Polystyrene Sulfonate Suspension-Recall Of 2 Lots Of Product Due To The Presence Of Yeast Which Could Affect Immunocompromised Patients
Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product.
See the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#SPSS
Governor Crist issues Executive Order 08-170 regarding Emergency Management for Tropical Storm Fay
On Saturday, August 16, 2008, Governor Crist issued Executive Order 08-170, declaring a state of emergency for the entire State of Florida due to the threat that Tropical Storm Fay imposes to the state
Section 4, paragraph D, of the executive order authorizes pharmacists in areas or counties covered under this executive order to dispense up to a 30-day emergency prescription refill in accordance with section 465.0275, Florida Statutes.
Further, section 8, of the executive order provides that medical professionals and workers, social workers, and counselors with good and valid professional licenses issued by states other than the State of Florida may render such services in Florida during this emergency for persons affected by this emergency with the condition that such services be rendered to such persons free of charge, and with the further condition that such services be rendered under the auspices of the America Red Cross or the Florida Department of Health.
Additionally, please note that section 252.358, Florida Statutes, requires that all health insurers, managed care organizations, and other entities that are licensed by the Office of Insurance Regulation and provide prescription medication coverage as part of a policy or contract waive time restrictions on prescription medication refills, which include suspension of electronic "refill too soon" edits to pharmacies, to enable insureds or subscribers to refill prescriptions in advance, if there are authorized refills remaining, and shall authorize payment to pharmacies for at least a 30-day supply of any prescription medication, regardless of the date upon which the prescription had most recently been filled by a pharmacist, when the following conditions occur: The person seeking the prescription medication refill resides in a county that is under a hurricane warning issued by the National Weather Service, is declared to be under a state of emergency in an executive order issued by the Governor, or has activated its emergency operations center and its emergency management plan.
DOH PRESS RELEASE: Medications in Disaster Situations (pdf - 24kb)
Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility
Actavis Totwa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey Facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.
The inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.
This action is not prompted by product complaints or health hazards associated with the products, which are all prescription medications. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. If patients should wish to obtain replacement medications and/or prescription, they should contact their health care professional or pharmacist. For more information regarding this market action, please visit http://www.actavis.us/en/media+center/..recallFAQ.htm.
Recall letters have been issued to wholesalers and retailers, instructing them to return product to Capital Returns, Milwaukee, WI.
Actavis Totowa, LLC is a United States subsidiary of Actavis Group hf. The voluntary action is limited only to Actavis Totowa products manufactured in the Little Falls, NJ facility listed below. Products manufactured by Actavis Elizabeth LLC, Actavis South Atlantic LLC, Actavis Mid Atlantic LLC or Actavis products manufactured in other facilities are thus not impacted by this recall.
The recalled products manufactured by the Little Falls facility are:
| Amantadine 100mg capsules | Meperidine & Promethazine capsules |
| Amibid DM ER tablets | Meperidine HCl 100 mg and 50 mg tablets |
| Amibid DM tablets | Methenamine Mandelate 0.5 g and 1.0 g tablets |
| Amidrine capsules | Mirtazapine 15 mg, 30 mg, and 45 mg tablets |
| Amigesic 500 mg caplets and 750 mg caplets | Mirtazapine OD tablets, 15 mg, 30 mg and 45 mg |
| Amitex PSE tablets | Multi-ret Folic 500 mg tablets |
| Bellamine S tablets | Multi-vita-bets 0.5 mg and 1.0 mg FL & FE tablets |
| Betaxolol 10 mg and 20 mg tablets USP | Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets |
| Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tablets | Naltrexone 50mg tablets |
| Carisoprodol & Aspirin tablets | Oxycodone & Acetaminophen 5/500mg capsules |
| Carisoprodol, Aspirin & Codeine tablets | Oxycodone HCl 5 mg, 15 mg and 30 mg tablets |
| Carisoprodol 350mg tablets | Oxycodone HCl 5 mg capsules |
| Chlordiazepoxide w/ Clidinium Bromide capsules | Pentazocine & Acetaminophen tablets |
| Chlorzoxazone 250mg | Pentazocine & Naloxone tablets |
| Cilostazol tablets 100mg | Phenazopyridine HCl 100 mg and 200 mg tablets |
| Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets | Phendimetrazine Tartrate 35mg tablets |
| Cyclobenzaprine HCL 5 mg and 10 mg | Phentermine HCl 37.5 mg tablets |
| Dexchlorpheniramine Maleate 4 mg and 6 mg tablets | Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules |
| Dipyridamole 25 mg, 50mg, and 75 mg tablets | Prenatal Formula 3 tablets |
| Glyburide 1.5 mg, 3.0 mg and 6.0 mg tablets | Prenatal Plus 27 mg FE tablets |
| Guaifenesin & Codeine Phosphate tablets | Prenatal Rx tablets |
| Guaifenesin & Phenylephrine tablets | Quinaretic 10mg/12.5mg, 20 mg/12.5 mg and 20 mg/25 mg tablets |
| Guanfacine 1.0 mg and 2.0 mg HCl tablets | Rifampin 300mg capsules |
| Hydrocodone & Homatropine tablets | Sodium FL 0.5 mg and 1.0 mg tablets |
| Hydromorphone HCl tablets | Tizanidine HCl 2 mg and 4 mg tablets |
| Hydroxyzine 10 mg, 25 mg and 50 mg tablets | Trimethobenzamide 300mg capsules |
| Hyoscyamine Sulfate 0.125 mg SL | Trimipramine Maleate 25mg, 50mg, 100mg capsules |
| Hyoscyamine Sulfate 0.375mg SR tablets | Trivita 1 mg FL tablets |
| Hyoscyamine Sulfate 0.125 mg (oral) tablets | Ursodiol capsules, 300mg |
| Isradipine 2.5 mg and 5 mg capsules | Vitacon Forte capsules |
| Loxapine 5 mg, 10 mg, 25 mg, and 50 mg capsules | Vitaplex Plus tablets |
| Meclizine Chewable 25 mg tablets | Vitaplex tablets (FC) |
| Meloxicam 7.5 mg and 15 mg tablets | Yohimbine HCl 5.4 mg tablets |
North Carolina Board of Pharmacy to allow Florida Pharmacists to Reciprocate (pdf - 9kb)
SureScripts, RxHub Merge to Expand e-Prescribing Network/p>
SureScripts and RxHub, the two largest networks for electronic prescription transactions in the United States, merged on June 30, 2008. The consolidation of both operations will form a single secure national network for the exchange of prescription related data among physicians, pharmacies, and prescription benefit management organizations. Both organizations were launched in 2001. RxHub was founded by three large prescription benefits management organizations, including CVS Caremark, Medco Health Solutions, and Express Scripts. SureScripts was formed by the National Association of Chain of Drug Stores and the National Community of Pharmacists Association. RxHub's expertise in patient identification and delivering drug benefit information to the physician at the point of care complements SureScripts' focus on electronic prescription routing from the physician's office to the pharmacy. The merger combines these strengths with a shared focus on more access to patient medication history, enabling physicians to access patient health information and transmit e-prescriptions and renewal requests to pharmacies. More information is available at www.surescriptsrxhub.com.
FDA Takes Action Against Companies Marketing Unapproved Injectable Colchicine /p>
Food and Drug Administration (FDA) is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine tablets are not affected by FDA's action at this time. The injectable form of colchicine is especially hazardous because the therapeutic index is very narrow. Adding to the problem, certain side effects that might alert the clinician that the dose is too high do not appear until the patient has already reached toxic levels. Because of its toxicity and the availability of safer therapies, injectable colchicine is rarely used to treat gout anymore, but some practitioners prescribe it to treat back pain. FDA states that the risks of this treatment outweigh the benefits. FDA also cautions pharmacies against compounding injectable colchicine products. Because of the drug's toxicity and narrow therapeutic index, any errors that occur during compounding can have potentially fatal consequences. More information is available in the FDA MedWatch Safety Alert at www.fda.gov/medwatch/safety/2008/safety08.htm#colchicine.
FDA MedWatch- Avastin (bevacizumab) and sunitinib malate- Reports of Microangiopathic Hemolytic Anemia In Patients Treated With This Combination/p>
Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Provider Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avastin
FDA MedWatch - The July 2008 FDA Patient Safety News Is Now Available/p>
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn.
FDA MedWatch- Recombinant Human Bone Morphogenetic Protein: Reports Of Life-threatening Complications In Cervical Spine Fusion/p>
FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone's responsibility, even if the event involves off-label use of medical devices.
Read the entire 2008 MedWatch Safety Summary, including the FDA's Public Health Notification regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Protein
FDA MedWatch -Rize 2 The Occasion Capsules And Rose 4 Her Capsules- Products Recalled Because They Contain An Undeclared Ingredient/p>
Jack Distribution, LLC issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, marketed as dietary supplements. The products were recalled because certain lots contained thiomethisosildenafil, an undeclared ingredient that is an analog of sildenafil, a FDA-approved drug used for Erectile Dysfunction. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have one of the above products should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking the products. See the manufacturer's press release for the specific lot numbers of the recalled products.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this recall at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Rize
MedWatch - Fluoroquinolones: Boxed Warning to be added for risk of tendon rupture and tendonitis/p>
FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.
This risk of tendinitis and tendon rupture is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria.
FDA Medwatch - Genentech informed healthcare professionals that an increased number of complaints were received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. The affected vials are NDC# 50242-0134-68, List # 15534. There is a risk that damaged vials may lead to a loss in sterility, which can cause infections in patients.
Healthcare professionals should inspect cartons of the product for signs of leakage, cracks and other damage to the vials, observe the vials during reconstitution, and check for loss of vacuum in the vials. See the manufacturer's letter for specific details and recommendations, including instructions in the event a compromised vial is discovered.
FDA MedWatch - 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product recalled: bacteria contamination/p>
Sage Products informed healthcare professionals of the voluntary recall of limited lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation product. The product was recalled because certain lots were found positive for Burkholderia cepacia (B. cepacia). B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as a weakened immune system or chronic lung diseases, particularly cystic fibrosis (CF) may be more susceptible to infections with B. cepacia. This organism is a known cause of infections in hospitalized patients and its effects range from no symptoms to serious respiratory infections, especially in patients with CF. The product was distributed to U.S. hospitals and medical centers nationwide and was shipped between 4/28/08 and 6/19/08. Healthcare professionals should stop using the product and coordinate the return of the product with the manufacturer.
Read the complete MedWatch 2008 Safety Summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ChlorhexidineFDA MedWatch- CellCept (mycophenolate mofetil)-Reports Of Progressive Multifocal Leukoencephalopathy In Patients Treated With CellCept/p>
Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information. The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with CellCept.
Read the entire 2008 MedWatch Safety Summary, including the manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/...safety08.htm#mycophenolateSwitch to HFA-Propelled Albuterol Inhalers Advised in Anticipation of CFC Ban
Food and Drug Administration (FDA) recently issued a public health advisory alerting patients, caregivers, and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after 2008. CFC-propelled albuterol inhalers are being phased out to comply with the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the US has agreed to phase out production and importation of ozone-depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed, or sold in the US after December 31. Three HFA-propelled albuterol inhalers have been approved by FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol is available as Xopenex HFA Inhalation Aerosol. More information is available on the FDA Web site at http://www.fda.gov/cder/mdi/albuterol.htm
Governor Charlie Crist signed SB 1360 (pdf) into law on June 23, 2008. This law becomes effective immediately upon becoming law unless otherwise provided in the bill language.
The bill, upon becoming law, removes the requirement that an applicant for pharmacist licensure by endorsement must have passed the licensure examination of the National Association of Boards of Pharmacy (NABP) or a similar nationally recognized exam within the last twelve years in order to qualify for licensure by this method.
Additionally, the bill requires the Board of Pharmacy to begin registering pharmacy technicians as of January 1, 2010.
Board of Pharmacy Legislative Update as of 6/17/08 (pdf - 607kb)
Governor Charlie Crist signed HB 7049 (pdf - 4mb) (2008) into law on June 17, 2008. This law becomes effective on July 1, 2008 unless otherwise provided in the bill language.
FDA MedWatxh Spring 2008 Issue of The FDA Safety Newsletter (pdf)
FDA MedWatch- Antipsychotics Associated With An Increased Risk Of Mortality In Elderly Patients Treated For Dementia-Related Psychosis/p>
FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNING section.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Information for Healthcare Professionals regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics
FDA MedWatch - Morphine Sulfate 60 mg Extended Release Tablets - Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness/p>
ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.
Read the MedWatch 2008 safety summary, including a link to the firm's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine
FDA MedWatch: Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)/p>
FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About n Ongoing Safety Review of Tumor Necrosis Factor (TFF) Blockers regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNFFDA MedWatch - The June 2008 FDA Patient Safety News is Now Available/p>
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
FDA MedWatch -Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula With Iron Powder- Product Recalled Because Of Oxidation/p>
Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutritional support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Calcilo
FDA Public Health Advisory: National Transition from Chlorofluorocarbon (CFC) Propelled Albuterol Inhalers to Hydrofluroalkane (HFA) Propelled Albuterol Inhalers
FDA is alerting patients, caregivers, and healthcare professionals to important information about albuterol inhalers. As part of a multi-year phase out, chlorofluorocarbon (CFC) propelled albuterol inhalers will not be available after December 31, 2008. Healthcare professionals should transition patients to the hydrofluoralkane (HFA) propelled albuterol inhalers now.
Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with obstructive airways disease, such as asthma and chronic obstructive pulmonary disease (COPD). The propellants (spray), CFC and HFA, push the albuterol into the lungs when a patient inhales. Currently there are three approved HFA propelled albuterol inhalers: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol. Each of the above four HFA propelled inhalers is a safe and effective replacement for CFC propelled albuterol inhalers. The manufacturers of HFA inhalers have increased production so that there is adequate supply of these products available now.
HFA propelled albuterol inhalers may taste and feel different than the CFC propelled albuterol inhalers. Notably, the force of the spray of an HFA propelled inhaler may feel softer than that of a CFC propelled inhaler. It is important to prime and clean the HFA propelled inhalers to prevent blockage in the inhaler device that will prevent the medicine from reaching the lungs. Each HFA propelled inhaler has different priming, cleaning, and drying instructions. Therefore, it is important to read and understand the instructions that come with each of the HFA propelled albuterol inhalers before using.
The national transition from CFC propelled to HFA propelled albuterol inhalers is due to an international environmental treaty called the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of Ozone Depleting Substances (ODS) including CFCs. Several CFC propelled inhalers containing other medicines have already been phased out. Over the next several years, other CFC propelled inhalers will be phased out. You can find more information at http://www.fda.gov/cder/mdi/albuterol.htm.
FDA MedWatch-Viril-ity Power (VIP) Tablets: Recall Of Supplement Product Because It Contains A Potentially Harmful Undeclared Ingredient/p>
International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs ( such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#VIP
FDA MedWatch- Xiadafil VIP Tablets- Product Contains Potentially Harmful, Undeclared Ingredient That May Cause Life-Threatening Side Effects/p>
FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.
Read the entire 2008 MedWatch Safety Summary, including a link to the Agency's News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Xiadaf
Trasylol (aprotinin injection) to be removed from all hospital pharmacies, available only under limited use agreement access/p>
Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.
Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.
Read the complete MedWatch safety summary, including links to the updated drug information page and the FDA news statement, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Trasylol
Drug Recall: Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP) as precaution
Contact: Stericycle customer service 1-888-276-6166
FOR IMMEDIATE RELEASE -- Morristown, NJ -- April 25, 2008 -- Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
The voluntary all lot recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than it appropriate.
Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.
Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.
Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found at www.actavis.us.
Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.
This recall is being conducted with the knowledge of the Food and Drug Administration.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/medwatch/.
FDA MedWatch- Enbrel (etanercept)-Prescribing Information Revised To Include A Boxed Warning Regarding The Risk Of Infection, Including Tuberculosis/p>
Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Enbrel
MedWatch - January 2008 Drug Safety Labeling Changes for 41 drugs now available on web - The January 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/SAFETY/2008/jan08_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/SAFETY/2008/jan08.htm
FDA MedWatch- Herbal Science International, Inc. Recalls Dietary Herbal Supplements Because They May Present A Serious Health Hazard To Consumers
Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.
Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue and a list of the recalled products at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Herbal
FDA MedWatch - Total Body Formula, Total Body Mega Formula found to contain hazardous levels of selenium
[UPDATE] The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium -- up to 200 times the amount of selenium indicated on the labels of the products. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products.
Read the complete MedWatch 2008 safety summary, including a link to the FDA News Release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TotalBody
FDA MedWatch- CellCept (mycophenolate mofetil) and Myfortic (mycophenolate acid)-Possible Development Of Progressive Multifocal Leukoencephalopathy
FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information. FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information. As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public.
Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Communication About an Ongoing Safety Review regarding this issue and prior MedWatch alerts regarding these products at: http://www.fda.gov/medwatch/...safety08.htm#mycophenolate
FDA MedWatch-Neupro (rotigotine transdermal system)- Product Recalled Due To The Formation Of Rotigotine Crystals In The Patches
Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson's disease. The product is being recalled because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA's Drug Shortage Information Sheet regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#neupro
FDA MedWatch-Exubera (insulin human rDNA origin) Inhalation Powder-Prescribing Information Updated To Include Information About Primary Lung Malignancies In Patients In Clinical Trials
Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of the limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.
Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and Dear Patient Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#exubera
FDA MedWatch-Cubicin (daptomycin for injection)- Potentially Significant Impurity Isolated From Reconstituted Product Stored In ReadyMED Pumps
Cubist Pharmaceuticals, Inc. informed healthcare professionals that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. MBT is used in the manufacture of rubber and has been reported to leach from rubber stoppers and syringe components into medicinal products in the past. Cutaneous exposure to MBT has been associated with dermal sensitization, and chronic administration of MBT to laboratory rodents has been associated with an increased risk of certain tumors. No MBT has been identified in reconstituted Cubicin in other standard types of infusion systems that have been tested. Healthcare professionals are advised to discontinue using ReadyMED elastomeric infusion pumps with Cubicin until the issue has been addressed.
Read the complete 2008 MedWatch Safety Summary, including a link to the Manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cubicin
FDA MedWatch - Heparin Sodium USP - Voluntary Nationwide Recall Because Two Lots Had Heparin-like Contaminant
Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.
Read the complete MedWatch 2008 safety summary, including a link to the firm press release, at:
http://www.fda.gov/medwatch/...safety08.htm#heparinsodium
FDA MedWatch - The April 2008 FDA Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
FDA MedWatch- Relenza (zanamivir) Changes To The WARNINGS AND PRECAUTIONS Sections Of Prescribing Information For Relenza About Postmarketing Reports Of Neurologic And Behavioral Symptoms
GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
Read the entire 2008 MedWatch Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Relenza
MedWatch - Tiotropium (marketed as Spiriva HandiHaler): ongoing safety review - possible increased risk of stroke
Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies ("pooled analysis"). Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.
It is important to interpret these preliminary results with caution. FDA is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke. FDA has not confirmed these analyses and while pooled analyses can provide early information about potential safety issues, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. Patients should not stop taking Spiriva HandiHaler before talking to their doctor, if they have questions about this new information. This early communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs.
Read the complete MedWatch 2008 safety summary, including a link to the Early Communication, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium
FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. A list of currently approved Medication Guides are available at http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.
See the MedWatch 2008 safety summary, including links to the Medication Guide and the current Prescribing Information for Avandia, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia
The Board of Pharmacy is pleased to announce that rule 64B16-26.1031, Florida Administrative Code; Influenza Immunization Certification Program became effective on March 20, 2008. To become certified by the Board of Pharmacy to administer influenza virus immunizations, a licensed pharmacist must complete a board-approved immunization administration certification course, submit an immunization administration certification application (pdf - 172kb), and meet the requirements set forth in section 465.189, Florida Statutes. For a list of board approved course providers, please visit www.cebroker.com.
FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone
On January 25, 2008, Cordis Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.
Read the complete MedWatch 2008 safety summary, including a link to the recall notice, at http://www.fda.gov/medwatch/safety/2008/safety08.htm#DuraStar
FDA NEWS RELEASE: FDA Warns Public of Contaminated Syringes
AM2 PAT, Inc., issues nationwide recall of all pre-filled syringe flushes
On January 25, 2008, the U.S. Food and Drug Administration (FDA) announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.
These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.
Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.
The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.
Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed the recalled syringes have developed blood infections.
The company voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples.
Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10 a.m. to 5 p.m. EST.
Any adverse reactions experienced with the use of the products, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.
MANUFACTURER: Sierra Pre-Filled, Inc., Angier, N.C.
PRODUCT DESCRIPTION:
Heparin Lock Flush Solution USP, All Strengths and Sizes
Normal Saline IV Flush Solution USP, All Strengths and Sizes
| Sierra Pre-Filled Inc. Products: | ||
| NDC# | CATALOG # | Product |
| 64054-1003-02 | 1003-02 | Heparin Lock Flush 100units/mL 5mL |
| 64054-1003-01 | 1003-01 | Heparin Lock Flush 100units/mL 3mL |
| 64054-3005-02 | 3005-02 | Heparin Lock Flush 10units/mL 5mL |
| 64054-3003-02 | 3003-02 | Heparin Lock Flush 10units/mL 3mL |
| 64054-3003-06 | 3003-06 | Heparin Lock Flush 10units/mL 3mL (6mL syringe) |
| 64054-3005-06 | 3005-06 | Heparin Lock Flush 10units/mL 5mL (6mL syringe) |
| 64054-0910-2 | 0910-12 | Normal Saline IV Flush 10mL |
| 64054-0905-2 | 0905-12 | Normal Saline IV Flush 5mL |
| 64054-0903-2 | 0903-12 | Normal Saline IV Flush 3mL |
| B. Braun Products: | ||
| NDC# | CATALOG # | Product |
| 64054-3005-02 | 513610 | Heparin Lock Flush 10units/mL 5mL |
| 64054-1003-01 | 513611 | Heparin Lock Flush 100units/mL 3mL |
| 64054-1003-02 | 513612 | Heparin Lock Flush 100units/mL 5mL |
| 64054-0903-2 | 513584 | Normal Saline IV Flush 3mL |
| 64054-0905-2 | 513586 | Normal Saline IV Flush 5mL |
| 64054-0910-2 | 513587 | Normal Saline IV Flush 10mL |
On January 24, 2008, Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.
Read the complete MedWatch 2008 Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Leukine
Governor Crist Launches Florida Discount Drug Card
Advisory: Methadone Hydrochloride Tablets USP 40 mg (Dispersible)
As of January 1, 2008, manufacturers of methadone hydrochloride tablets 40 mg (dispersible) have voluntarily agreed to restrict distribution of this formulation to only those facilities authorized for detoxification and maintenance treatment of opioid addiction, and hospitals. Manufacturers will instruct their wholesale distributors to discontinue supplying this formulation to any facility not meeting the above criteria.
Methadone is a long-lasting opioid medication used in the treatment of pain and narcotic addiction. The 5mg and 10 mg formulations indicated for the treatment of pain will continue to be available to all authorized registrants, including retail pharmacies. The 40 mg methadone formulation is indicated for the detoxification and maintenance treatment of opioid addiction. The 40 mg strength is not FDA approved for use in the management of pain. Thus, the distribution and availability of the 40 mg formulation will be limited to registrants in only those settings using the 40 mg formulation for the appropriate indication.
The DEA and pharmaceutical industry agree that the reported increase in methadone-related adverse events merits action and further agree to a united effort to assure that methadone is properly distributed, consistent with its approved uses. Industry and the federal entities involved commit to monitor the progress of this initiative.
For more information, please visit the DEA 's website at www.deadiversion.usdoj.gov
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat adults with type 2 diabetes. An association between Byetta and acute pancreatitis is suspected in some of these cases. Amylin Pharmaceuticals, Inc. has
agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label.
Healthcare professionals should be alert to the signs and symptoms of acute pancreatitis and instruct patients taking Byetta to seek prompt medical care if they experience unexplained, persistent, severe abdominal pain which may or may not be accompanied by vomiting. If
pancreatitis is suspected, Byetta should be discontinued. If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.
Read the complete MedWatch 2007 Safety Summary including a link to Information for Healthcare Professionals, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta
Bush Signs FDA Reform Bill; Legislation Provides for Establishment of Tracking Standards
President Bush signed HR 3580, the Food and Drug Administration Amendments Act of 2007, into law on September 27, 2007. Among other provisions, the law reauthorizes and expands the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act. The legislation expands Food and Drug Administration (FDA) authority to regulate marketed drugs, establish a surveillance system to monitor and assess the safety profile of drugs on the market, reauthorize and modify programs that evaluate the use of drugs and devices by children, and expand federal databases that track information on certain clinical trials. The law also requires the Department of Health and Human Services to establish a standardized numerical identifier that must be applied to prescription medications at the point of manufacture, and to develop standards to serve as guidelines in the implementation of track-and-trace and package-level identification technology to monitor prescription medications through the supply chain.
FDA Cracks Down on Companies Marketing Unapproved Hydrocodone Products
FDA will take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, the agency announced on September 28, 2007. The action does not affect other hydrocodone formulations, which have FDA approval. FDA requires companies marketing unapproved hydrocodone products labeled for use in children younger than 6 years of age to cease manufacture and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products by December 31, 2007 and must cease further shipment in interstate commerce by March 31, 2008. FDA warns that failure to meet these deadlines could subject violators to legal action. More information is available on the FDA Web site at
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01713.html.
The Department of Health Recognizes October as American Pharmacists Month (pdf - 51kb)
On Friday, September 28, 2007, The National Association of Boards of Pharmacy (NABP) announced that the North American Pharmacist Licensure Examination (NAPLEX®) program is being reinstated in all Prometric testing centers, effective October 5, 2007. Candidates who have been deemed eligible for the NAPLEX by their respective state boards of pharmacy will have the option of scheduling an appointment to sit for the examination from October 5 forward. Prometric's customer service department will begin accepting calls from candidates for examination appointments and rescheduling of appointments on Monday, October 1, 2007. If a candidate has an existing appointment, either selected before the suspension of the NAPLEX or rescheduled by Prometric during the suspension, it will be the candidate's responsibility to reschedule that appointment if the candidate desires an earlier appointment date and time.
Medicaid Tamper-Resistant Prescription Information (pdf - 33kb)
The Florida Medicaid program, in accordance with section 409.912 (37)(a)5, Florida Statutes, requires medical practitioners to use a counterfeit-proof prescription blank produced by an approved vendor when writing hard copy prescription orders for Medicaid recipients for any covered service under the Florida Medicaid Prescribed Drug Services Program. All prescribers must use prescription blanks produced according to minimum requirements by one of the approved vendors. The requirement has been in effect in Florida since July 1, 2001, and meets the requirements of the new federal law becoming effective on October 1, 2007.
For more information, please refer to the Agency for Health Care Administration (AHCA) website: http://floridamedicaid.consultec-inc.com/index.jsp, then Click on Provider Support, then Click on Counterfeit Proof Prescriptions, then Click on Counterfeit Proof Prescription Vendor list. If you would like to speak directly to an individual, please contact the Bureau of Pharmacy Services at 487-4441
On Sept. 25, the Senate unanimously passed S. 2085, a bill to push back to April 1, 2008 the effective date for prescribers and pharmacists to comply with a provision requiring all Medicaid prescriptions to be written on tamper-resistant paper to avoid fraud. Acting quickly, the U.S. House approved a bill including a similar provision (HR 3668) the following day. To avoid a conference committee to reconcile the two slightly different bills and expedite final passage, the Senate took up the House-passed bill on last night, approved it and sent it to the President to be signed. If President Bush signs the measure, the transition to tamper resistant pads for written Medicaid prescription would be delayed for six months to next April 1st.
FDA Update: Drug Shortage; Drug to be Discontinued; Ethmozine (moricizine hydrochloride) 200mg, 250g, and 300mg tablets (updated 9/17/07)
Florida Pharmacist License Renewal Information (pdf - 13kb)
Foreign Graduate Rule Update - Effective August 8, 2007 (pdf - 18kb)
Vaccine Administration Authority (pdf - 11kb)
Suboxone and Subutex: Verifying Prescribers (pdf - 46kb)
FDA Warns Consumers About Counterfeit Drugs (pdf - 28kb)
National Pharmacy Compliance News (pdf - 14kb)
Federal Pseudoephedrine Law (pdf - 22kb)
Weight Loss Medications (pdf - 112kb)
FDA Warns Consumers About Dangerous Ingredients in "Dietary Supplements" Promoted for Sexual Enhancement (pdf - 37kb)
Governor signs 5 bills making them into laws and affecting the pharmacy licensees. (pdf - 39kb
| MISSION: | To protect, promote & improve the health of all people in Florida through integrated state, county, & community efforts. |
| VISION: | To be the Healthiest State in the Nation |
| PURPOSE: | To protect the public and make Florida the healthiest state in the nation through health care licensure, enforcement, and information. |
| FOCUS: | To be the nation's leader in quality health care regulation. |
| VALUES: | I CARE (Innovation, Collaboration, Accountability, Responsiveness, Excellence) |
