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Compounded methylprednisolone acetate injection under FDA investigation
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The FDA, along with the CDC and Tennessee Board of Pharmacy, is currently investigating seven reports of adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC, in Newbern, Tenn., according to an agency press release.
The reports are all from patients who received preservative-free methylprednisolone acetate (80 mg/mL) by injection. Clinical information about these patients is pending; at least one infection appears to be fungal, according to the release.
As a precaution, the FDA is currently recommending that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further notice.
“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,” they wrote.
Physicians and consumers are encouraged to report adverse events or quality problems associated with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm