FDA Probes Tennessee Pharmacy Said to Have Issued Tainted MedicationOct 29, 2013
The U.S. Food and Drug Administration (FDA) is investigating reports of patient complications caused by possibly contaminated medications made by a Tennessee specialty pharmacy.
On Friday the FDA said the investigation was focused on seven reports from patients who had gotten steroid injections from the Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tennessee, CBS News reports.
The injections contain methylprednisolone acetate, the drug at the center of last year's deadly outbreak of fungal meningitis, according to CBS News. Back then, more than 55 people died and over 740 others were sickened after receiving tainted injections from a Massachusetts compounding pharmacy, the New England Compounding Center, which has since shut down. Such steroid injections are usually used to treat pain and reduce inflammation.
At least one of the recent cases appears to be a fungal infection, according to the FDA, and the agency recommends that doctors stop using any sterile drugs from Main Street and quarantine them until further notice.
The Tennessee department of health said the affected patients were in Illinois and North Carolina and had received the injections after Dec. 6, 2012. At least 13 states received suspect product, including Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.
Compounding pharmacies mix unique medications for patients who, for various reasons, cannot be treated with standard FDA-approved medication. But compounding pharmacies operate in a legal gray area, in between state and federal regulations, and some produce and ship drugs in quantities that rival the large drug makers, but without the same level of oversight that those manufacturers are subject to.
Since last year's meningitis outbreak, the FDA has stepped up inspections of compounding pharmacies across the country, triggering several national recalls of potentially contaminated medications, according to CBS News. Injectable medications, which must be produced under highly controlled, sterile conditions, have been a particular concern.
Congress is now considering legislation that would give the FDA direct oversight over compounders, CBS News reports.