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Adverse Events Among Florida Patients
Receiving Injections of Methylprednisolone
Acetate (MPA) compounded by the Main Street
Family Pharmacy (Newbern, TN) –
June 26, 2013
Following
an initial announcement on May 29, 2013, the
Florida Department of Health (FDOH) has
continued its partnership with the Food and
Drug Administration (FDA), Centers for
Disease Control and Prevention (CDC),
Florida state partners, and other state
health departments to monitor, investigate
and respond to reports of adverse reactions
associated with steroid injections.
Adverse
reactions have been linked to injections of
preservative-free methylprednisolone acetate
(“MPA”, “PF”, 80mg/mL) in particular, which
is compounded at Main Street Family
Pharmacy, LLC., of Newbern, TN (MSFP). On
June 13, 2013, FDA and CDC laboratories,
working together, reported the
identification of bacterial and fungal
growth in unopened vials from two separate MSFP lots of the 80 mg/mL PF formulation.
Main
Street has voluntarily initiated a recall of
all sterile products, including MPA, in
cooperation with state and federal
authorities. Out of an abundance of caution,
the FDA recommends all health care providers
stop using any sterile products from Main
Street and isolate them until further
guidance is provided.
Three
Florida facilities in two counties were
listed as having received MPA from Main
Street Family Pharmacy: Brevard County (The
Orthopedic Spine Back Center and Dr. Parvesh
Bansal of Melbourne) and Washington County
(Family Health Care of Chipley).
FDOH has
notified each of these facilities and,
together with the facilities, 1436 of the
1437 potentially exposed patients have been
contacted by phone or letter to notify them
and provide them with guidance on seeking
health care if they develop any of the
following symptoms, depending on the site of
injection.
|
Site of injection |
Possible Signs/Symptoms of Infection |
|
Intramuscular or Intralesional |
Localized pain, redness, drainage,
swelling |
|
Peripheral Joint and neighboring
structures |
Localized pain, redness, swelling,
warmth |
|
Spine or Paraspinal region |
Headache, fever, stiff neck,
sensitivity to light, localized pain
or redness near the injection site,
focal weakness or numbness |
Any
Florida health care licensee requiring
assistance to report a potential adverse
reaction following an injection of MPA is
encouraged to contact their local county
health department. The exact source of these
adverse reactions is unknown at this time,
and FDOH will continue working with state
and federal partners throughout this ongoing
investigation.
As of June 26, 2013, FDOH has confirmed 14
cases of Florida residents experiencing
adverse reactions associated with steroid
injections of MPA that was produced by Main
Street Family Pharmacy. To date, no reports
of meningitis or life-threatening infections
have been reported. At this time, each of
Florida’s currently identified cases of
adverse reaction are associated with skin
abscesses following intra-muscular
injections of MPA.
Links
to additional information on the multi-state
outbreak and the response by FDOH and
partners is available at the following web
sites:
CDC Outbreak
Investigation
FDA
Update (June
13, 2013)
For a complete
list of FDOH
press releases,
please visit the
Florida
Department of
Health Online
Newsroom
FDOH Press
Release
(May 24, 2013)
FDOH Press
Release
(May 29, 2013)
Tennessee Press
Release
(May 24, 2013)
Illinois Press
Release
(May 24, 2013)
North Carolina
Press Release
(May 28,
2013) |
