FDA Investigates Compounded Medication Tied to Meningitis Outbreak - - BioPharm International

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FDA Investigates Compounded Medication Tied to Meningitis Outbreak



FDA announced that it is working closely with the Centers for Disease Control (CDC) to identify the source of an outbreak of meningitis among patients who had received an epidural steroid injection. According to the CDC, as of Oct. 7, 2012, 91 cases of meningitis linked to the injections and seven deaths have been reported across nine states.

All affected patients received injections of the same product, preservative-free methylprednisolone acetate (80mg/mL), an injectable steroid produced and distributed by the New England Compounding Center (NECC) in Framingham, Massachusetts. FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from NECC, and 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.

The NECC, following an earlier recommendation by FDA that none of the firm's compounded products be used, announced a voluntary recall of all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. A complete list of recalled products can be found on FDA’s website. FDA is requesting that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.

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