U.S. FDA finds bacteria in New England Compounding drugs

(Reuters) - U.S. health officials have found bacteria in lots of an injected steroid and a heart drug made by New England Compounding Center, the pharmacy linked to contaminated steroids that have claimed the lives of at least 28 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 an injectable steroid, while cardioplegia is used during heart surgery.

The FDA had previously confirmed the presence of a deadly fungus in two different NECC batches of a different injectable steroid 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.

Federal health officials previously said they were investigating whether two other NECC products could be linked to fungal infections in three patients, including two who had undergone heart surgery.

NECC, located in Framingham, Massachusetts, shut down in early October and recalled all of its products.

The FDA said tests for fungus in the lots of betamethasone and cardioplegia are still underway.

The latest tally from the Centers for Disease Control and Prevention lists 386 cases of fungal meningitis and 28 deaths linked to injections of NECC steroids.

(Reporting by Deena Beasley; Editing by Andre Grenon and Lisa Shumaker)

Source: http://news.yahoo.com/fda-finds-bacteria-england-compounding-drugs-223833752.html

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