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Update on Fungal Meningitis

Posted Oct 19 2012 1:17pm


[10-18-2012] CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013).  The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections.  Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues. 

CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up. 

Clinicians are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or  www.fda.gov/medwatch .

Health care professionals and patients may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.

There is now available a Patient Notification Letter on the FDA "Update on Fungal Meningitis" webpage under the "Related Information" section. This letter template is for healthcare professionals notifying patients administered a drug produced by the New England Compounding Center (NECC) that has been recalled.

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857
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