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FDA announces more contaminated NECC pharmaceuticals

Last week we discussed a deadly fungal meningitis outbreak which was linked to contaminated pharmaceuticals from a Massachusetts specialty pharmacy. Authorities say that problems at the New England Compounding Center were documented for years but the pharmacy had always managed to avoid severe fines and public exposure of the unsanitary conditions at its facilities.

The Food and Drug Administration recently announced that two more drugs from the NECC were contaminated due to poor standards at the facility. The drugs are a back steroid called preservative-free betamethasone, and a heart surgery medication called cardioplegia solution. Authorities say that these drugs were contaminated with bacteria and may add to the wave of pharmaceutical litigation that has already begun against the company.

Fungal meningitis infections have been linked to NECC’s preservative-free methylprednisolone acetate (MPA) injections. At least 386 infections have been recorded and 28 deaths have been blamed on the injections.

“Although final laboratory results on additional samples are still pending, the previous finding of fungal contamination of MPA and recent finding of bacterial contamination of injectable betamethasone and cardioplegia solution reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products,” the FDA said in a statement. “All NECC products are subject to NECC’s recall announced on Oct. 6, 2012.”

Source: FDA, “Multistate outbreak of fungal meningitis and other infections,” Nov. 1, 2012