FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised

[Update 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.

There is now available a Patient Notification Letter¹ 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.

[Update 10/16/2012] On 10/15/12 the health care facility notified CDC that the initial report of two transplant patients has been revised to one patient who received cardioplegia solution from NECC. The 10/15/12 statement has been revised to reflect this information.

[Posted 10/15/2012]

AUDIENCE: Pharmacists, Risk Managers, Pain Medicine

ISSUE: As a result of the ongoing investigation of New England Compounding Center (NECC), a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.

In addition, two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported. Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.

BACKGROUND: On October 4, the FDA advised providers to not use any NECC products. On October 6, NECC announced a recall of all its products. See the complete list of all products subject to this recall.² The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use.

RECOMMENDATION: FDA advises healthcare professionals to follow-up with patients who were administered any injectable medication from or produced by NECC, including injectable ophthalmic drugs used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. Healthcare professionals and medical care organizations should inform patients who received the NECC products noted above of the symptoms of possible infection and instruct patients to contact their healthcare provider immediately if they experience any of these symptoms.

FDA advises healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm³
Download form⁴ or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Healthcare professionals 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.

[10/18/2012 - Update on Fungal Meningitis⁵ - FDA]

[10/17/2012 - (Spanish) Questions and Answers⁶ - FDA]

[10/17/2012 - (Spanish) Fungal Meningitis Outbreak Statement⁷ - FDA

[10/16/2012 – Questions and Answers on Fungal Meningitis Outbreak⁸ – FDA]

[10/15/2012 - FDA Statement on Fungal Meningitis Outbreak⁹]
[10/15/2012 - Multistate Fungal Meningitis Outbreak Investigation¹⁰ - CDC]