CDC and FDA Provide Updates on Meningitis Outbreak and Related Investigation

Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have confirmed that the contaminated intrathecal methylprednisolone injections compounded by the New England Compounding Center (NECC) are linked to the multistate outbreak of fungal meningitis and joint infections. As of October 23, 2012, CDC reports that there are 308 cases of fungal meningitis, including 23 deaths, and four cases of peripheral joint infections. Of the 308 cases, a total of 70 have occurred in Tennessee, 68 in Michigan, 41 in Virginia, and 40 in Indiana, with the other 89 spread across Florida, Georgia, Idaho, Illinois, Maryland, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, and Texas.

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 one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013), as reported in an FDA update. The agencies state that the laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections, and that testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables 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.

CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up. 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.