Distributed via Health Alert Network
December 3, 2012, 16:55 ET (4:55 PM ET)
Summary: As part of the ongoing investigation of the multistate outbreak of fungal meningitis and other infections, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continue to test medical products from the New England Compounding Center (NECC) in Framingham, Mass. CDC and FDA are reporting today additional microbial contamination identified in NECC products, which updates the November 1, 2012 Health Alert Network advisory. This update includes the following key points:
On September 26, 2012, NECC voluntarily recalled three lots of preservative-free methylprednisolone acetate (PF) 80mg/ml1 associated with the multistate outbreak of fungal meningitis and other infections. As previously confirmed by CDC and FDA, the fungus Exserohilum rostratum was identified from two different lots of NECC-supplied, preservative-free methylprednisolone acetate (Lot #06292012@26 and Lot #08102012@51); testing on the third implicated lot of preservative-free methylprednisolone acetate (Lot #05212012@68) has yet to identify fungal growth. Two types of fungus not known to be human pathogens were also identified from product from the two tested lots, namely Rhodotorula laryngis and Rhizopus stolonifer. Among these fungal organisms, only Exserohilum rostratum has been associated with human infections in this outbreak.
On October 6, NECC expanded its recall to include all products in circulation that were distributed from its facility in Framingham, Mass. As part of the ongoing investigation, FDA and CDC have been testing various NECC products for evidence of contamination. Laboratory testing at CDC and FDA has found bacterial and/or fungal contamination in unopened vials of betamethasone, cardioplegia, and triamcinolone solutions distributed and recalled from NECC, as shown in the table below.
Bacterial and Fungal Contamination
6 mg/mL injectable –5 mL per vial
Paenibacillus pabuli/amolyticus, Bacillus idriensis, Bacillus flexus, Bacillus simplex, Lysinibacillus sp., Bacillus niacini,
Kocuria rosea, Bacillus lentus
Bacillus niabensis, Bacillus circulans
12 mg/mL injectable – 5 mL per vial
Bacillus lentus, Bacillus circulans, Bacillus niabensis, Paenibacillus barengoltzii/timonensis
6mg/mL injectable – 5 mL per vial
Bacillus lentus, Bacillus firmus, Bacillus pumilus
6 mg/mL injectable – 5 mL per vial
Penicillium sp., Cladosporium sp.
Bacillus lentus, Bacillus circulans
40 mg/mL injectable – 2 mL per vial
Aspergillus tubingensis, Penicillium sp.
40mg/mL injectable – 10 mL per vial
265.5 mL per bag
Bacillus halmapalus/horikoshii, Brevibacillus choshinensis
*Identification of other bacteria for this product is pending.
Recommendations to Healthcare Providers
FDA released a MedWatch Safety Alert on October 15 stating that the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC is of significant concern. The safety alert further advised healthcare providers to follow-up with patients who were administered any of these products purchased from or distributed by NECC on or after May 21, 2012. A sample notification letter to assist with this process is available.
CDC’s recommendations to healthcare providers for diagnosing and treating symptomatic patients who have received NECC products have not changed as a result of the laboratory findings reported here. CDC continues to recommend that clinicians remain vigilant for the possibility that infections may have resulted from injection of NECC products, and that routine laboratory and microbiologic tests, including bacterial and fungal cultures, should be obtained as deemed necessary by treating clinicians.
There has been no prior systematic surveillance for adverse events following epidural steroid injections; however, infection is a known, although likely rare, risk that has been documented in the medical literature. To date, although CDC is aware of reports of illness in patients who have received these medications, including some patients who had evidence of meningeal inflammation, CDC and other public health officials have no reports of laboratory-confirmed bacterial or fungal meningitis, or spinal or paraspinal infections caused by these products. The available epidemiological and laboratory data do not, at this time, support evidence of an outbreak of infections linked to usage of non-methylprednisolone NECC products.
However, because it is possible that some of the organisms listed in the table above can cause human disease, clinicians should continue to include bacterial and/or fungal infection in the differential diagnosis when evaluating symptomatic patients who were exposed to these medications, including consideration of empiric antifungal therapy.
Consultation with an infectious disease specialist is strongly encouraged to help make treatment decisions in these cases. If the evaluation of these patients is suggestive of fungal infection, please consult existing CDC treatment guidance associated with this outbreak.
Physicians should continue to report infections potentially related to NECC products to FDA's MedWatch and to state health departments.
NECC lots of methylprednisolone acetate (PF) 80mg/ml:
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013
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