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Possible Medication Contamination in Southern Illinois Prompts FDA Investigation – May 28, 2013

Problems associated with a steroid injection of five patients from the Southern Illinois town of Herrin has led to an investigation by the FDA of a Tennessee specialty pharmacy.   The five individuals in Southern Illinois developed skin infections in the hip and buttock area and at least one of two additional cases in North Carolina appears to involve a fungal infection.  The skin infections involve an abscess formation at the injection site.  Public health officials are unsure whether the cause of the abscess is a germ, infection or contaminant, and are running tests to determine that.

The individuals in Southern Illinois received injections at the Logan Primary Care Clinic between the dates of January 3rd and February 21st of this year.  The North Carolina patients received their injections at a clinic in Greenville, N.C.  The source of the potentially contaminated medication is Main Street Family Pharmacy, a compounding pharmacy from Newbern, Tennessee.  Main Street Pharmacy is supporting the FDA’s recommendation to cease injections of the subject medication until the investigation is finished.   The Tennessee pharmacy has shipped steroid injections to thirteen states. Logan Primary Care in Herrin, Illinois has ceased injections of the medication and removed it from utilization.  They have notified roughly 2000 patients who received injections between December and April.

These cases raise special concern because the medication in question contains methylprednisolone acetate, which was the drug at the heart of the deadly outbreak  of fungal meningitis that killed 55 people and sickened 740 others last year after receiving injections from a Massachusetts compounding pharmacy.   Both of these instances have involved what is called a compounding pharmacy which creates a particular pharmaceutical product to fit the unique needs of a patient. Critics of compounding pharmacies have concerns that they are regulated not by the FDA but by state agencies, sometimes allowing them to act like larger pharmaceutical manufacturers but without the stricter regulations of the FDA.

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