October 18, 2012
FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised - Update
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 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 percent 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 the New England Compounding Center (NECC) that has been recalled.
Read the MedWatch Alert, including a link to the FDA Statement at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm