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Fungal, bacterial growth found in steroid
Tenn. pharmacy under investigation for links to reported infections
UPDATED 11:16 AM EDT Jun 10, 2013
(CNN) —The
U.S. Food and Drug Administration has identified bacterial and fungal
growth in unopened vials of a steroid injection from a Tennessee
pharmacy under investigation for links to reported infections.
Main
Street Family Pharmacy of Newbern, Tenn., issued a voluntary recall
nationwide of all lots of sterile products that the pharmacy compounds
on May 28. Products with a use by date on or before Nov. 20, 2013, are
subject to the recall.
The steroid in question is
preservative-free methylprednisolone acetate. Samples from two separate
batches were found to have microbial growth in them, the FDA said.
"At
this point in FDA's investigation, the sterility of all sterile
products produced by Main Street is of significant concern and the
products should not be used," the FDA said.
As of Thursday, the
Centers for Disease Control and Prevention reported 24 cases of
infection from four states -- Arkansas, Florida, Illinois and North
Carolina. Most of these people developed skin and soft tissue infections
after receiving the intramuscular injection of the steroid.
Read More Here
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Posted June 13, 2013 3 PM ET
At a Glance:
- Status: On-going Investigation
- Reported Cases: 26
- States reporting cases: 4
- Recall: Yes
Distribution maps
States reporting cases *
Map showing states with reported cases.
States that received recalled MPA
States that have received recalled methylprednisolone acetate product from Main Street Family Pharmacy since December 1, 2012.
This website will be updated on Thursdays by 3pm ET.
Initial Announcement
May 30, 2013
Main
Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers
of Adverse Reactions Associated with Steroid Injections
State,
Federal Health Officials Investigate Reports of Adverse Events among
Patients Receiving Methylprednisolone Acetate Injections
Summary of Investigation
This information is preliminary and will be updated as additional details become available.
June 13, 2013
CDC
and FDA have identified the bacteria and fungi cultured from unopened
vials of preservative-free MPA from Main Street Family Pharmacy (MSFP)
in Newbern, TN. These
findings
are important reminders that healthcare providers should ensure that
all recalled products from MSFP are no longer in use. In addition,
complaints from patients exposed to products from MSFP should be taken
seriously and should be promptly reported to both FDA
MedWatch and the health department.
In addition to the findings above, 4 of the 26 cases meeting the CDC
case definition* have had bacteria or fungi detected from wounds: 2 patients had
Enterobacter cloacae and
Klebsiella pneumoniae, 1 had mixed bacterial culture not otherwise identified, and 1 had fungus highly suggestive of an
Aspergillus sp.,
although further studies are needed for confirmation. Although bacteria
and fungi have been isolated from unopened vials of MPA from MSFP, it
is not possible to determine which infections are due to this
contamination event versus other factors including improper handling
and/or administration of medications at the injection facility.
Clinicians
are reminded that they should 1) use individual containers of
compounded or preservative-free medicine for a single-patient only, and
2) promptly report to MedWatch any infection that might be related to a
medication or medical device, even absent a recognized outbreak, as
these reports can allow for early detection of a possible contamination
event.
Note: The next CDC web update is scheduled for Thursday, June 20.
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