AAPM&R Member Update
5/25/2013: New FDA Alert for an Injectible Steroid
The U.S. Food and Drug Administration (FDA) is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.
The FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.
Adverse events have been reported from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these infections appears to be fungal in nature.
An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication. As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.
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