Tuesday, October 16, 2012

FDA Adds More Drugs to Watch List for Fungal Meningitis Outbreak, Asks Providers for Assistance

Late yesterday, the U.S. Food and Drug Administration (FDA) issued an updated MedWatch Safety alert on the ongoing meningitis outbreak and announced that it had received a report of a patient possibly contracting fungal meningitis from an epidural injection of a product made by the New England Compounding Center (NECC). The product, Triamcinolone Acitonide, is an injectable steroid similar to methylprednisone acetate - the NECC injectable steroid associated with the previously reported cases of meningitis. On Oct. 4, the FDA advised providers not to use any NECC products, and on Oct. 6, NECC issued a recall of its products.

In addition to the two aforementioned injectable steroids, the FDA has received reports of two transplant patients with Aspergillus fumigates infections who were administered an NECC cardioplegic solution during surgery; the FDA is still investigating whether the cardioplegic solution played a role or if other potential sources more likely explain the infection in these transplant patients.

The FDA advised health care professionals and organizations to follow up with patients who were given any injectable medication produced by NECC or on whom a cardioplegic solution purchased from or produced by NECC after May 21, 2012, was used during surgery. The FDA asks that providers notify patients of the symptoms that might indicate a potential infection and ask that they immediately contact their provider if they experience any of these symptoms. The FDA also advises providers to report any of these potential infections to the FDA's MedWatch Safety Information System at www.fda.gov/MedWatch/report.htm. Health care professionals may call FDA's Drug Information Line at 855-543-DRUG (3784) to get the most recent information on the outbreak.

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