Note: Under Florida law, e-mail addresses are public records. If you do not want your e-mail address released in response to a public records request, do not send electronic mail to this entity. Instead, contact this office by phone or in writing.
This information is provided in the most accessible format possible. To request a more accessible version of the documents on this page, please send an email to: MQA_Pharmacy@doh.state.fl.us
• New laws impacting health care regulation
• Counterfeit-proof Rx vendor info
• Senate Bill 1986 regarding Health Care Fraud and Convictions
• Guidelines for Drug Donations
Many Florida health care professionals want to know how they can help the Haitian nation by donating prescription drugs. It is important that donated drugs sent into a disaster area are needed and reach the area in need to insure that the donated drugs are helpful rather than harmful.
The Department can not provide legal advice on the donation of prescription drugs and the following information is intended only to provide health care providers with assistance in navigating Florida's drug donation rules. The Department is not authorized to approve individual donation programs; however the following excerpt from section 64F-12.011, Florida Administrative Code, Wholesale Distribution of Prescription Drugs-Exceptions and Specific Distributions Authorized, addresses the donation of prescription drugs.
(3) A person authorized to possess non-dispensed prescription drugs can donate prescription drugs that are not misbranded or adulterated to a charitable organization that has been granted an exemption under s. 501(c)(3) of the Internal Revenue Code of 1986, as amended, and that is authorized to possess prescription drugs provided the transfer is not for sale or trade and the donor receives no financial benefit (except for tax benefits related to charitable contributions) either directly or indirectly. Records to document the transfer must comply with Section 499.0121(6), F.S., and paragraph 64F-12.008(2)(c), F.A.C. The World Health Organization (WHO) has developed Guidelines for Drug Donations (see below) to insure that drug donations are appropriate.
• Reporting Requirement - Section 456.063(3), Florida Statutes, states: Licensed health care practitioners shall report allegations of sexual misconduct to the department, regardless of the practice setting in which the alleged sexual misconduct occurred.
• NEW! Important New REMS Information from Purdue Pharma L.P.
Purdue Pharma, L.P. is introducing a Risk Evaluation and Mitigation Strategy (REMS) for OxyContin® (oxycodone HCl controlled-release) Tablets CII to educate physicians and other prescribers, pharmacists, patients, and caregivers about the potential for abuse, misuse, overdose, and addiction from exposure to OxyContin® Tablets.
Healthcare professionals and patients who have questions about prescribing, dispensing, or taking OxyContin® Tablets should contact the Purdue Medical Services department at (888)726-7535, prompt #1.
Statement of Purdue Pharma L.P. Regarding OxyContin® (oxycodone HCl controlled-release) Tablets Risk Evaluation and Mitigation Strategy http://www.purduepharma.com/News-and-Media/Pages/News-Archives.aspx
• NEW! DEA FAQ's on Electronic Prescriptions for Controlled Substances
• NEW! Information for Pharmacies who supply DME (pdf - 57kb)
• New! Late Breaking NASCSA NEWS - DEA Publishes Rules on Electronic Prescribing of Controlled Substances
The US Drug Enforcement Administration's Interim Final Rule on e-prescribing was published in today's Federal Register. The effective date of the rule is June 1, 2010 and comments are due on the same date.
The revised regulations provide practitioners with the option of electronically writing prescriptions for controlled substances. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These regulations are in addition to, not a replacement of, the existing rules. The regulations provide pharmacies, hospitals, and practitioners the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of control on controlled substances.
A copy of the interim rule is found at: http://edocket.access.gpo.gov/2010/pdf/2010-6687.pdf.
• NEW! Important Notice - Levothyroxine Sodium has been Removed from the Negative Formulary List Effective March 18, 2010 (doc - 140kb)
• NEW! Important Notice: Pain Management Clinic Registration Requirements (doc - 28kb)
• NABP e-News - USP Issues Recall of National Formulary 28
On January 8, 2010, United States Pharmacopeial Convention (USP) recalled United States Pharmacopeia 33 - National Formulary 28 (USP 33 - NF 28) that was issued November 1, 2009. The recall was initiated due to errors that occurred when monographs were redesigned into a new format intended to improve ease of use. USP reports that while many of the monographs were successfully redesigned, a significant number contained errors. Thus, USP 32 - NF 27 is official at this time and remains official until further notice. USP plans to reissue the online and a CD version of USP 33 - NF 28 in March 2010 with an official date six months after reissue. USP also plans to reissue a print volume of new and revised monographs.
More information about the recall and the reissue of USP 33 - NF 28 can be found in the USP public notice at http://www.usp.org/USPNF/recallStatement.html
• FDA Warns of Unapproved and Illegal H1N1 Drug Products Purchased Over the Internet (pdf - 16kb)
• New FDA Web Page Lists Disposal Instructions for Select Medicines (pdf - 16kb)
• Annual Permits Required for Weighing and Measuring Devices - Beginning July 1, 2009 (pdf - 928kb)
• Tamiflu: Important Prescribing Information (pdf - 13kb)
• Levothyroxine Sodium is included on the Florida Negative Drug Formulary (pdf - 101kb)
• Declaration (doc - 170kb)
• FDA Issues Draft Guidance for Industry on Drug Anticounterfeiting
Mon, 13 Jul 2009 11:25:00 -0500
The U.S. Food and Drug Administration today issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug.
• FDA Approves Injectable Form of Ibuprofen
Thu, 11 Jun 2009
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.
April 2009 SUMMARY: The Ryan Haight Online Pharmacy Consumer Protection Act, which was enacted on October 15, 2008, amended the Controlled Substances Act and Controlled Substances Import and Export Act by adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the Internet. DEA is issuing an interim rule to amend its regulations to implement the legislation and is requesting comments on the interim rule.
Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (pdf - 239kb)
Press Release
• FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market Wed, 08 Apr 2009 16:02:00 -0500
Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.
• NEW! Caraco Pharmaceutical Laboratories, Ltd. Announces a Nationwide Voluntary Recall of All Lots of Digoxin Tablets Due to Size Variability (March 31)
Caraco Pharmaceutical Laboratories, Ltd., a generic pharmaceutical company, announced today that all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd.
• FDA MedWatch - Metoclopramide-containing drugs: chronic use linked to tardive dyskinesia
FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with ! chronic metoclopramide treatment.
Read the MedWatch 2009 safety summary, including a link to the FDA News Release, at: http://www.fda.gov/medwatch/safety/.../safety09.htm#Metoclopramide
• FDA MedWatch - Zonisamide (marketed as Zonegran, and generics) can cause metabolic acidosis in some patients
FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary.
Read the MedWatch 2009 safety summary, including a link to the "Information for Healthcare Professionals" sheet, at http://www.fda.gov/medwatch/safety/2009/safety09.htm#Zonisamide
• MedWatch - Public Health Advisory describes cases of PML associated with the use of Raptiva
FDA issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva. The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML. The Public Health Advisory provides recommendations for healthcare providers and patients when treatment with this product is considered.
Read the MedWatch safety summary, including links to the Public Health Advisory and News Release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Raptiva
• MedWatch - CellCept (mycophenolate mofetil) - Medication Guide to be distributed to every patient who fills a CellCept prescription
FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.
Read the complete MedWatch 2009 Safety summary including links to the Dear Healthcare Professional and Dear Pharmacist letters, the new Medication Guide and the current Prescribing Information, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept
• FDA MedWatch - Xigris (Drotrecogin alfa):Early Communication about an Ongoing Safety Review re: increased bleeding events/mortality
FDA is aware of a recently published study, a retrospective medical record review of 73 patients who receive Drotrecogin alfa (activated), marketed as Xigris, indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (Gentry et al.; Crit Care Med 2009).The study reported an increased risk of serious bleeding events and of death in patients with sepsis and baseline bleeding risk factors who received this product. Serious bleeding events occurred in 7 of 20 patients (35%) who had a bleeding risk factor vs. only 2 of 53 (3.8%) patients without any bleeding risk factors. The finding by Gentry et al. of an increased risk of death and serious bleeding events in patients treated with Xigris who also have baseline bleeding risk factors is consistent with the information in the current product label. Prescribers should refer to the product label for the specific contraindications, warnings, and, precautions and carefully weigh the increased risk of bleeding against the benefits of Xigris.
FDA is working with the manufacturer to further evaluate the incidence of serious bleeding events and mortality in patients who received Xigris. FDA will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months.The FDA urges both healthcare professionals and patients to report side effects from the use of Xigris to the FDA's MedWatch Adverse Event Reporting program.
Read the complete MedWatch 2009 Safety summary, including links to the Early Communication and the Prescribing Information, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Xigris
• MedWatch - Ethex Corp. recalls prescription prenatal vitamin and iron supplement products
Nationwide recall expanded to include various prescription prenatal vitamin and iron supplement products. Read the MedWatch 2009 safety summary, including links to the Ethex Press Releases, at http://www.fda.gov/medwatch/safety/2009/safety09.htm#Ethex
• Drug shortage: Metoprolol succinate extended release tablets
• Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidances, workshop announcements.
• Good Reprint Practices. The Food and Drug Administration announced in a Federal Register notice of January 13. 2009, the availability of a guidance for industry entitled ''Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.'' The guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA- approved drugs or biologics or FDA-approved or cleared medical devices to healthcare professionals and healthcare entities. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-452.pdfand http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0053-gdl.pdf
• Good Importer Practices. The Food and Drug Administration announced in a Federal Register notice of January 13. 2009, on behalf of several members of the Interagency Working Group on Import Safety (agencies) the availability of a draft guidance for industry entitled ''Good Importer Practices.'' This draft guidance document provides general recommendations to importers on possible practices and procedures they may follow to increase the likelihood the products they import are in compliance with applicable U.S. safety and security requirements. The recommendations provided here are intended to promote and facilitate an assessment by importers of a product's life cycle so the importer may make sound decisions about how best to address the product's potential to cause harm and to facilitate compliance with U.S. requirements. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-453.pdfand http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2009-D-0675-gdl.pdf
• Enrollment of Certain Populations in Clinical Drug Trials. The Food and Drug Administration announced in a Federal Register notice of January 13, 2009, that the agency is seeking information and comments on issues related to the enrollment of certain populations in clinical drug trials. Particularly, we are requesting information and comments from medical product manufacturers, institutional review boards (IRBs), patient groups, universities, researchers, community groups, and other interested parties. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires recommendations be included in a report to Congress addressing best practice approaches on increasing the participation of elderly populations, children, racially and ethnically diverse communities, and medically underserved populations in clinical drug trials. FDA requests that those with information on possible approaches to increase participation of these groups in clinical drug trials submit comments. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-450.pdf
• Adverse Event Reporting. The Food and Drug Administration announced in a Federal Register notice of January 15, 2009, the availability of a guidance for industry entitled ''Adverse Event Reporting--Improving Human Subject Protection.'' This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to institutional review boards (IRBs). FDA developed this guidance in response to concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event reports are inhibiting, rather than enhancing, the ability of IRBs to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs. Elsewhere in this issue of the Federal Register, FDA is issuing the final rule entitled ''Institutional Review Boards; Registration Requirements.'' http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-683.pdfand http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2007-D-0202-gdl.pdf
• Registration of Institutional Review Boards. The Food and Drug Administration issued a final rule on January 15, 2009, to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The registration information includes contact information (such as addresses and telephone numbers), the number of active protocols involving FDA-regulated products reviewed during the preceding 12 months, and a description of the types of FDA-regulated products involved in the protocols reviewed. The IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to IRBs. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-682.pdf
• Secure Supply Chain. The Food and Drug Administration announced in a Federal Register notice of January 15, 2009, an opportunity for sponsors and foreign manufacturers of finished drug products and active pharmaceutical ingredients (APIs) intended for human use imported by a secure supply chain to apply to participate in a voluntary Secure Supply Chain (SSC) pilot program to be conducted by FDA's Center for Drug Evaluation and Research and Office of Regulatory Affairs. The goal of the pilot program is to allow FDA to determine the practicality of developing a secure supply chain program. The information obtained from this pilot program will assist FDA in its determination. A Secure Supply Chain program would assist the agency in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the agency to focus its resources on imported drugs outside the program that may pose such risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and APIs imported into the United States that meet the criteria for selection under the program. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-791.pdf
• New Guidance. The Food and Drug Administration announced in a Federal Register notice of January 16, 2009, the availability of a draft guidance for industry entitled ''Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages.'' This draft guidance is being issued under the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA to develop standardized numerical identifiers for prescription drugs. We are also requesting responses from interested stakeholders to questions posed in this Federal Register notice related to the draft guidance. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-833.pdfand http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2009-D-0001-gdl.pdf
• Submission of Bioequivalence Data. The Food and Drug Administration announced in a Federal Register notice of January 16, 2009, that the agency is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because we now believe that data from additional BE studies may be important in our determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD), and are relevant to our evaluation of ANDAs in general. In addition, such data will increase our understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-884.pdf
• New Guidance. The Food and Drug Administration announced in a Federal Register notice of January 21, 2009, the availability of a guidance for industry entitled "Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007" dated January 2009. The guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications as described in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-1183.pdfand http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0224-gdl.pdf
• Ther-Rx Corporation Issues Nationwide Voluntary Recall of Products
• MedWatch - Nationwide recall of multiple ETHEX generic drug products due to manufacturing deficiencies
FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. 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. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.
Read the complete MedWatch 2009 Safety summary, including links to the firm's press release and two previous alerts, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Ethex
• MedWatch - Venom HYPERDRIVE 3.0 contains undeclared sibutramine, poses risks for abuse, addiction, and increased blood pressure and heart rate
FDA notified consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement but containing sibutramine, an undeclared drug product and a controlled substance with risks for abuse or addiction. When present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate, and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke. The product was sold via distributors and in retail stores nationwide and was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743. Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects.
Read the MedWatch 2009 safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Venom
• FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug
• MedWatch - Plavix [Clopidogrel bisulfate] FDA safety review to evaluate differences in efffectiveness, genetic factors, potential drug interactions
FDA notified healthcare professionals that the makers of Plavix have agreed to work with FDA to conduct studies to obtain additional information that will allow a better understanding and characterization of the effects of genetic factors and other drugs (especially the proton pump inhibitors (PPIs)) on the effectiveness of clopidogrel. FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic differences in the way the body metabolizes clopidogrel or that using certain other drugs with clopidogrel can interfere with how the body metabolizes clopidogrel. These studies should lead to a better understanding about how to optimize the use of clopidogrel. The FDA recognizes the importance of obtaining these data promptly. The drug manufacturers have agreed to a timeline for completing the studies and FDA will review the new information expeditiously and will communicate its conclusions and any recommendations to the public at that time. It could take several months to complete the studies and analyze the results. Until further information is available FDA recommends the following:
Healthcare providers should continue to prescribe and patients should continue to take clopidogrel as directed, because clopidogrel has demonstrated benefits in preventing blood clots that could lead to a heart attack or stroke.
Healthcare providers should re-evaluate the need for starting or continuing treatment with a PPI, including Prilosec OTC, in patients taking clopidogrel.
Patients taking clopidogrel should consult with their healthcare provider if they are currently taking or considering taking a PPI, including Prilosec OTC.
Read the complete MedWatch 2009 Safety summary, including a link to the Early Communication, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#plavix
• FDA Alerts Public about Danger of Skin Numbing Products
The U.S. Food and Drug Administration today issued a Public Health Advisory to alert consumers, patients, health care professionals, and caregivers about potentially serious and life-threatening side effects from the improper use of skin numbing products. The products, also known as topical anesthetics, are available in over-the-counter (OTC) and prescription forms.
• FDA MedWatch - Drug Safety Newsletter, Volume 2, Issue 1, 2009
The Drug Safety Newsletter (DSN), Volume 2, Issue 1, 2009 is now available at http://www.fda.gov/Drugs/.../DrugSafetyNewsletter/default.htm
DSN is published online quarterly, and provides information for healthcare professionals about the findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new drugs. The newsletter is intended to complement other FDA methods of communicating drug safety information to the public. FDA also hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals.
• FDA MedWatch - Topical Anesthetics: Public Health Advisory issued regarding serious hazards of using skin numbing products
FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products.
Read the MedWatch 2009 safety summary, including links to the Public Health Advisory and "Dear Colleague" letter, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Anesthetics
• FDA MedWatch - Singulair (montelukast): updated information to March 2008 Early Communication
FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.
Read the complete MedWatch Safety summary, including a link to the updated early communication and the original March 2008 communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair
• FDA MedWatch - Ezetimibe/Simvastatin - Update of Safety Review
• Greenstone LLC Voluntary Recall of Azithromycin 500 mg Tablets (pdf - 406kb)
• MedWatch - Innohep (tinzaparin sodium) Dear Healthcare Professional Letter issued re: increased risk of death in renal impaired elderly
[UPDATE 12/31/2008] Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.
Read the complete MedWatch 2008 Safety summary, including a link to the Dear Healthcare Professional letter and the December 2 FDA Ongoing Safety Review, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep
• Health Insurance Portability and Accountability Act (HIPAA) Information
| 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) |
