viernes, 12 de octubre de 2012

Drug Safety and Availability > FDA Statement on Fungal Meningitis Outbreak

FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are currently coordinating a multistate investigation of fungal meningitis among patients who received an epidural steroid injection with a potentially contaminated product. This form of meningitis is not contagious. Several of these patients also suffered strokes that are believed to have resulted from their infection. The investigation has expanded to include fungal infections from other steroid injections.
FDA has been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. FDA has observed fungal contamination in a sealed vial of methylprednisolone acetate collected from NECC, and is in the process of conducting additional testing to confirm the species of the fungus.
Additional information can be obtained via the following links:
CDC - Multistate Meningitis Outbreak Investigation
FDA Statement on Fungal Meningitis Outbreak

FDA Statement on Fungal Meningitis Outbreak

[UPDATE: 10-6-2012] On October 6, 2012, the New England Compounding Center (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.
NECC press release and a complete list of the firm's compounded products.

[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.