FDA Statement on Fungal Meningitis Outbreak

[10-5-2012] FDA is working closely with the CDC and state partners to investigate an outbreak of meningitis among patients who had received an epidural steroid injection.  Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. 

That product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts.  CDC’s interim data show that all infected patients received injection with this product.  As of Oct 3, 2012, NECC has voluntarily shut down.

FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from NECC.  FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus.  As part of the ongoing investigation, FDA will continue to work closely with CDC and state authorities to determine whether this sample taken from the product matches the organism found in patients. We are working diligently to expedite that process.

Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.  

Users should also notify FDA of any complaints or problems associated with these products.  These reports may be made to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088 or on line at www.fda.gov/medwatch/report.htm.