FDA: 2 More NECC Drugs Contaminated

By Daniel J. DeNoon
WebMD Health News

Reviewed by Louise Chang, MD

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 ongoing 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 NumberMicrobial Identification
Betamethasone [email protected]Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp.
Betamethasone [email protected]Bacillus niabensis, Bacillus circulans
Betamethasone [email protected]Bacillus lentus, Bacillus circulans
Cardioplegia solution [email protected]Bacillus halmapalus, Brevibacillus choshinensis

Two of these bacteria -- Bacillus idriensis and Bacillus circulans -- have been linked to rare cases of human disease. The FDA says 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.

So far, the CDC has not received any reports of laboratory-confirmed bacterial infections linked to these NECC products.

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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SOURCES:News release, FDA.CDC web site.

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