Outbreak of Meningitis Associated With Contaminated Intrathecal Steroid Injection

At least 231 cases of fungal meningitis, including 15 deaths, have been reported to be caused by intrathecal methylprednisolone injections compounded by the New England Compounding Center (NECC). Of the 231 cases reported as of October 16, 2012, a total of 59 have occurred in Tennessee, 35 in Virginia, 47 in Michigan, and 30 in Indiana, with the other 60 spread across Florida, Idaho, Illinois, Maryland, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, and Texas. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are coordinating a multi-state investigation of the meningitis outbreak, and CDC reports that interim data show that all infected patients received an injection with preservative-free methylprednisolone acetate (80mg/ml) prepared by NECC, located in Framingham, MA.

NECC has released a statement claiming that it “is working closely with the Massachusetts Department of Public Health, the Massachusetts Board of Pharmacy and other regulators to identify the source of infection in patients who received injections of methylprednisolone acetate. Upon notification of incidents of infection, NECC immediately initiated a voluntary recall of this product on Sept. 26. As part of this process, we have voluntarily suspended operations while we assist authorities in their investigation.” On October 3, 2012, the North Carolina Board of Pharmacy summarily suspended NECC’s permit. The Board’s order can be found at www.ncbop.org.

The lot numbers of the drugs that are suspected of being contaminated are:

• 05212012@68
• 06292012@26
• 08102012@51

“On October 6, NECC expanded its previous recalls to include all products currently in circulation that were compounded at and distributed from its facility” in Framingham, MA, CDC indicates in an official Health Advisory. Updates on the outbreak and the investigation are available on the CDC Web site.