FDA: 2 More NECC Drugs Contaminated

Nov. 1, 2012 — Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.

The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of the on-going outbreak of fungal meningitis. The FDA previously found fungus growing in unopened vials of the company’s methylprednisolone injectable steroid.

Now the FDA has found bacteria in three lots of the NECC’s betamethasone, another injectable steroid, and in cardioplegia solution, a drug used to stop the heart during transplant operations. It’s not yet clear whether the drugs also carry fungal contamination or other kinds of bacteria.

Tests of each lot of the drugs found a different combination of bacteria:

Product and Lot Number Microbial Identification Betamethasone 08202012@141 Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp. Betamethasone 07032012@22 Bacillus niabensis, Bacillus circulans Betamethasone 07302012@52 Bacillus lentus, Bacillus circulans Cardioplegia solution 09242012@55 Bacillus halmapalus, Brevibacillus choshinensis

Two of these bacteria — Bacillus idriensis and Bacillus circulans — have been linked to rare cases of human disease. The FDA states that for patients treated with these drugs, “the clinical significance of these results is not known.”

All NECC drugs were recalled on Oct. 6. The FDA has not estimated how many patients were treated with the contaminated betamethasone or cardioplegia solution before that date.

As of today, there have been 377 cases of fungal meningitis and nine cases of fungal joint infections in people who received NECC drugs. Twenty-eight of these people have died.

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Submited at Friday, November 2nd, 2012 at 12:00 am on Uncategorized by hilman
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