CDC and FDA Continue Investigation as Number of Fungal Meningitis Cases Climbs

October 31, 2012

Topics: Compounding, Patient Safety, Pharmacies

As the investigation continues into the multistate outbreak of meningitis due to contaminated methylprednisolone injections compounded by the New England Compounding Center (NECC), Centers for Disease Control and Prevention (CDC) reports that at least 363 individuals have been affected. Further, CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80 mg/ml) from two of the three implicated lots from NECC (Lot #06292012@26, BUD12/26/2012 and Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections.

As of October 30, 2012, CDC reports that there are 363 cases of fungal meningitis, including 28 deaths, and seven cases of peripheral joint infections. Of the 363 cases, a total of 93 have occurred in Michigan, 74 in Tennessee, 45 in Indiana, and 44 in Virginia, with the other 107 spread across Florida, Georgia, Idaho, Illinois, Maryland, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, and Texas.

Testing on the third implicated lot of methylprednisolone acetate and other NECC injectable medications continues. CDC does not have firm evidence that fungal infections have been caused by exposure to other NECC products. Updates on the meningitis outbreak and the investigation are available on the CDC Web site. Health care providers are requested to report any related adverse events to the FDA MedWatch program by calling 800/332-1088 or completing the online report.