Reuters: Regulatory News: U.S. FDA finds bacteria in two New England Compounding products

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U.S. FDA finds bacteria in two New England Compounding products Nov 1st 2012, 22:05 Thu Nov 1, 2012 6:05pm EDT * Bacteria found in lots of skin cream, heart drug * Tests for fungus still pending * FDA says findings reinforce contamination concerns Nov 1 (Reuters) - U.S. health officials have found bacteria in lots of skin cream and a heart drug made by New England Compounding Center, the pharmacy responsible for contaminated steroids that have claimed the lives of 29 people. The Food and Drug Administration said it identified different types of bacteria in three separate recalled batches of NECC's preservative-free betamethasone and in a single batch of NECC-supplied cardioplegia solution. Betamethasone is a glucocorticoid steroid cream used to treat itching or other skin irritation, while cardioplegia is used during heart surgery. The FDA had previously confirmed the presence of a deadly fungus in two different NECC batches of injectable steroids tied to the national fungal meningitis outbreak. That drug, preservative-free methylprednisolone acetate, was used to treat back and joint pain. The agency said it did not know how significant the bacterial contamination was in terms of the risk for human disease and said it had not received reports of confirmed cases of infection related to the organisms found in the two products. However, the findings "reinforce the FDA's concern about the lack of sterility in products produced at NECC's compounding facility," the agency said in a statement. NECC, located in Framingham, Mass., shut down in early October. The FDA said tests for fungus in the lots of betamethasone and cardioplegia are still underway. Link this Share this Digg this Email Reprints

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