Other NECC Products Implicated in Meningitis Outbreak

Megan Brooks

October 15, 2012

October 15, 2012 — A patient with possible meningitis potentially associated with epidural injection of triamcinolone acetonide made by New England Compounding Center (NECC) in Framingham, Massachusetts, has been identified and reported to the US Food and Drug Administration (FDA), the agency said today.

The patient was identified through active surveillance and reported to the FDA as part of an ongoing investigation into the meningitis outbreak from potentially contaminated vials of methylprednisolone acetate made by NECC.

Until today, all cases of meningitis identified had been associated with 3 now-recalled lots of methylprednisolone acetate.

In addition, the FDA reported today that 2 transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have also been reported to FDA.

"Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection," the FDA said on its Web site.

The agency has not confirmed that these 3 infections were, in fact, caused by an NECC product. "FDA continues to evaluate these reports, and when the agency obtains additional information, it will be promptly relayed to the public," the FDA said.

However, at this point in the investigation, the FDA said, "the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection."

"At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection," the FDA said.

Products from NECC can be identified by markings that indicate New England Compounding Center by name, by its acronym (NECC), and/or by the company logo found here.

As previously reported by Medscape Medical News, the FDA and Centers for Disease Control and Prevention (CDC) have advised healthcare professionals to stop using any product produced by NECC, all of which have been recalled.

A complete list of all recalled products from NECC can be found on the FDA Web site.

The FDA is advising clinicians to follow up with any patient who received an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. At this time, the FDA does not urge patient follow-up for NECC products of lower risk, such as topical agents (eg, lotions, creams, and eyedrops not used in conjunction with surgery) and suppositories.

The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light), and altered mental status. Symptoms for other possible infections may include fever; swelling, increasing pain, redness, and warmth at the injection site; visual changes and pain, redness, or discharge from the eye; chest pain; or drainage from the surgical site (infection within the chest).

The FDA said it "recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today's announcement. We ask you to use your clinical judgment in deciding which patients are at risk and contact those patients in whatever communications mode you prefer, whether it is email, phone or letter. Face-to-face communication with patients is not necessary."

The FDA is asking clinicians to promptly report any suspected adverse events after use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.

As of today, the CDC said a total of 214 cases (including the 15 deaths) have been reported across 15 states.

Because the investigation into the meningitis outbreak is ongoing and rapidly changing, the CDC is providing regular clinical guidance updates (and new updates) for healthcare providers, including: