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Contamination Identified in Additional Medical Products from Pharmacy Linked to Ongoing Deadly Fungal Meningitis Outbreak


As of November 5, 2012, 419 cases of fungal meningitis have been reported to the CDC, including 30 deaths. These cases include 409 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus ten peripheral joint infections (e.g., knee, hip, shoulder, or elbow). No deaths have been associated with peripheral joint infections.

 

The FDA and CDC laboratories have identified bacteria present in two additional recalled New England Compounding Center (NECC) products: three separate lots (batches) of NECC-supplied preservative-free injectable betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.  Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA).

 

Product testing has identified bacterial contamination with several Bacillus species and closely related bacterial organisms in unopened vials of betamethasone and cardioplegia solution that were distributed and later recalled by NECC on October 6, 2012. The clinical significance of these results is not known. These bacteria are commonly found in the environment and have been rarely reported as a cause of human disease; it is not known how product contamination with these species might affect patients. Nevertheless, clinicians should consider these product findings when reviewing laboratory results from patients who have been exposed to a NECC product, since Bacillus and related bacteria are often considered in clinical results to be possible skin contaminants. Although clinical infection is possible, as of Nov. 1, the 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.

 

Additional microbial organisms may be identified in recalled NECC products as additional laboratory testing is completed. The CDC continues to investigate reports of potential infections in patients receiving other NECC products. Fungal cultures for injectable 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 injectable 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 (originally reported to you in the Oct. 15 Scalpel Weekly News). Testing on the third implicated lot of MPA (Lot #05212012@68), as well as other NECC products, is ongoing.

 

Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. In this outbreak symptoms typically have appeared 1 to 4 weeks following injection, but it’s important to know that longer and shorter periods of time between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection.

 

See the CDC Report

 

See the CDC Health Advisory

 

See the FDA Update

 

See the Original Recall

 

 

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