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FDA CONTINUES TO INVESTIGATE FUNGAL MENINGITIS OUTBREAK

FDA CONTINUES TO INVESTIGATE FUNGAL MENINGITIS OUTBREAK

The federal investigation into a Massachusetts-based pharmacy has widened as more of its products have been found to be contaminated with bacteria. The New England Compounding Center (NECC) is the specialty pharmacy blamed for a national outbreak of fungal meningitis, which has sickened more than 430 and killed dozens. The fungal meningitis outbreak is linked to the NECC's preservative-free methylprednisolone acetate (MPA), an injectable steroid used to treat back pain.

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention recently reported that they found bacteria in two other NECC products, preservative-free injectable betamethasone and cardioplegia solution. Betamethasone is a steroid that reduces swelling and allergic reactions. Cardioplegia solution is used during heart surgery to paralyze muscles.

The FDA has noted that the clinical significance of the new bacterial contamination discoveries is unknown. The bacteria, Bacillus circulans, have only rarely been reported as the cause of human infections and no infections related to the two drugs have been reported.

"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."

The owner of the NECC, Barry Cadden, recently appeared at a House hearing into the outbreak, but repeatedly refused to answer questions regarding the sterility and safety practices at the pharmacy. Cadden repeatedly invoked the Fifth Amendment during the hearing of the Energy and Commerce subcommittee on oversight and investigations.

Copies of the FDA investigation report indicate that health inspectors found vials of NECC drugs containing black bacteria and white mold. Sterilization equipment at the NECC was also observed to be discolored and wet.

It is unclear how many pharmaceutical product liability and wrongful death cases will ultimately be filed in connection with the fungal meningitis outbreak. Some hospitals may also face liability in this case because investigations have shown that some of the tainted back steroids were kept at hospitals long after their shelf life. Generally, nonsterile injections should be discarded after three days. Some physicians kept NECC back steroids for weeks before giving them to patients. This may have allowed the already-contaminated products to become more dangerous before they were injected into patients.

Source: FDA, "Multistate outbreak of fungal meningitis and other infections."

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