Thursday, October 18, 2012

FDA: Exserohilum Found In Unopened Vials Of NECC Methylprednisolone

 

 

# 6645

 

An update this afternoon (h/t Catbird on FluTrackers) from the FDA indicating that tests have confirmed the presence of Exserohilum rostratum in unopened vials of methylprednisolone acetate prepared by the New England Compounding Center (NECC).

 

Update on Fungal Meningitis

[10-18-2012] CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratumin 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.