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

Thu Nov 1, 2012 7:19pm EDT

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(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)

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Comments (2)
santefe wrote:
There is a petition to request greater regulation of drug compounding facilities on the ”We the People” WhiteHouse.gov website. Compounding facilities need greater regulation to meet the medical standards that warrant Americans’ trust in healthcare.
You can view and sign the petition here (you may have to cut and paste in your browser):

Nov 02, 2012 8:11am EDT  --  Report as abuse
tyg wrote:
How many states are now seriously inspecting compounders? Can states really regulate compounders? No national laws will pass when there are companies with lawyers to defend their right to claim what a former Conigliaro employee claimed. The person essentially was quoted as there being a culture where the drug production during one night was worth more than the lives of all of his employees combined. Obviously, the drug compounding is worth more than the 28 lives lost so far. Who knows how many people have actually suffered from the culture of greedy compounders, drug suppliers, indifferent FDA and state public health agencies. Are they any different than the Conigliaros?

Nov 02, 2012 11:25pm EDT  --  Report as abuse
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