More Compounded Drugs Contaminated With Bacteria

Four lots of preservative-free betamethasone and cardioplegia solution from the New England Compounding Center have now tested positive for bacterial contamination, according to the FDA. FDA and CDC laboratories have identified the presence of bacteria in 3 separate batches of NECC's betamethasone and in a single lot of its cardioplegia solution.

The tainted lots, and the bacteria tests confirm they've been contaminated with, include the following:

• 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 choshinensi

These common bacteria have rarely been reported as causes of human disease, and the CDC says it doesn't know how products contaminated with these species might affect patients. Clinical infection is possible, but the CDC hasn't received reports of laboratory-confirmed cases of infection due to Bacillus or the other contaminating microbes. The CDC advises healthcare providers to consider these findings when reviewing lab results of patients who've received NECC products, but isn't recommending changes to diagnosing and treating symptomatic patients.

"These results and the finding of fungal contamination of methylprednisolone acetate reinforce the FDA's concern about the lack of sterility in products produced at NECC's compounding facility and serve to underscore that hospitals, clinics, and health care providers should not use any NECC-supplied products," says the FDA. The CDC notes that additional microbial organisms may be identified in recalled NECC products as further tests are completed.

The number of deaths in the fungal meningitis outbreak centering on NECC stands at 28, while the number of cases has reached 386.

Betamethasone is a corticosteroid used to treat the inflammation, swelling, and pain as a standalone injection or after eye surgery. Cardioplegia solution is used to protect the myocardium during cardiac surgery.

Stephanie Wasek