jueves, 1 de noviembre de 2012

Multistate outbreak of fungal meningitis and other infections

Update on NECC Products: Samples of betamethasone and cardioplegia solution test positive for bacterial contamination

[11-01-2012] The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are reporting laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution. Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA).

The FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.

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

The clinical significance of these results is not known. Both Bacillus idriensis and Bacillus circulans have been rarely reported as a cause of human disease. CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of Nov. 1, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to betamethasone or cardioplegia solution from NECC.

Fungal cultures for betamethasone and cardioplegia solution are pending and the presence of additional microbial organisms and/or fungus in these products cannot be ruled out at this time.

Although final laboratory results on additional samples are still pending, the previous finding of fungal contamination of MPA and recent finding of bacterial contamination of betamethasone and cardioplegia solution 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. All NECC products are subject to NECC’s recall announced on Oct. 6, 2012.

As previously confirmed by the CDC and FDA, the fungus Exserohilum rostratum was identified from 2 different lots of NECC-supplied, preservative-free MPA (Lot #06292012@26 and Lot #08102012@51), which have been associated with the outbreak of fungal meningitis and other infections in patients. Testing on the third implicated lot of MPA (Lot #05212012@68), as well as other NECC products, is ongoing.

Health care professionals and patients may call the FDA's Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the Ameridose recall and speak directly to a pharmacist.

The FDA asks health care professionals and consumers to report any adverse reactions to the FDA's MedWatch Program by fax at 800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch¹.