FDA warns of seven infections tied to steroid injections from Tennessee pharmacy

May 26, 2013

FDA warns of seven infections tied to steroid injections from Tennessee pharmacy

The Main Street Family Pharmacy is currently on probation as a result of a recent inspection.

The U.S. Food and Drug Administration said on Friday that it received reports of seven illnesses tied to steroid injections compounded by Main Street Family Pharmacy. According to a news release from the Tennessee Department of Public Health, the reports of adverse events came from patients in Illinois and North Carolina.

According to CNN, the seven patients developed abscesses.

The FDA, the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy are working together to investigate the reports. Currently, these organizations are gathering and processing information, as well as communicating with impacted facilities and patients.

The FDA warned health care providers not to administer any products labeled as sterile from Main Street Family Pharmacy and to confine them until additional instructions are given.

According to the FDA, the reports of infections are all from patients who obtained preservative free  methylprednisolone acetate by injection. MPA is usually injected to reduce inflammation.

The Tennessee Department of Public Health said it is known that MPA products were sent to facilities in 13 states. Health departments and facilities in these states are being made aware of the investigation so they can assist if necessary.

Clinical information about these patients is still pending, but the Tennessee Department of Public Health said that no reports of meningitis or other life-threatening infections have be received so far.

At the moment, the FDA and the aforementioned organizations are conducting an investigation into the exact source of these infections, but these cases are linked to a potentially contaminated medication.

The FDA wants health care workers and patients to report illnesses experienced with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program.

According to the Tennessee Department of Public Health, the Main Street Family Pharmacy is currently on probation as a result of a recent inspection. The Main Street Family Pharmacy has agreed to halt sterile compounding pending resolution of the current investigation.


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