Fungal Meningitis Outbreak: FDA Advises Additional Patient Notification
[UPDATE 10/22/2012]: The FDA has made available a list of customers who received products that were shipped on or after May 21, 2012 from NECC. The FDA is updating its previous recommendation that follow-up with patients be done when the following three conditions are met:
- The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
- The medication was shipped by NECC or administered to patients on or after May 21, 2012.
The 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 New England Compunding Center (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.
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 NECC that has been recalled.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm