FDA Releases Customer Lists for NECC Regarding Fungal Meningitis Outbreak

To help facilities and providers determine whether they have received contaminated products affected by the multistate fungal meningitis outbreak, the FDA has posted on its website two lists of customers who received products from New England Compounding Center’s (NECC) Framingham, Mass., facility on or after May 21, 2012. Earlier this month, after patients who had received an epidural steroid injection contracted fungal meningitis, the FDA advised medical professionals to stop using all products manufactured by NECC. On October 6, NECC issued a voluntary recall of all products currently in circulation that were compounded at and distributed from its Framingham facility.

Customer Lists

The first list released by the FDA includes customer names and addresses since May 21, 2012, and is organized by state. The second list includes the same information as the first but also includes a description, quantity, and ship date of the items purchased, and is alphabetized by customer name. The FDA underscored that the lists were based on information provided by NECC, so it cannot vouch for their accuracy. In addition, products shipped by the company and facility information could be incomplete.

Case Count

The CDC reported 317 cases with fungal infections linked to steroid injections, including 24 deaths, in 17 states. Of these 317 cases, 312 were cases on fungal meningitis or stroke due to fungal meningitis, and five were cases of peripheral joint infections. No deaths have been associated with peripheral joint infections.

The CDC and state health departments estimate that 14,000 people have received injections with the three implicated lots of methylprednisolone and nearly 97 percent have been contacted for follow up.

FDA’s Recommendations

The FDA continues to recommend that providers follow up with patients if the following conditions exist: (1) the medication was an injectable product purchased from or produced by NECC (including ophthalmic drugs that are injectable or used in conjunction with eye surgery); (2) the medication was shipped by NECC on or after May 21, 2012; and (3) the medication was administered to patients on or after May 21, 2012. The FDA does not recommend following up for lower-risk NECC products, such as topicals and suppositories.

 The FDA and CDC urge patients to be vigilant about the onset of meningitis. The symptoms include fever, headache, stiff neck, nausea and vomiting, sensitivity to light, and altered mental status. In this outbreak symptoms have appeared one to four weeks, but longer and shorter times from injection to the onset of symptoms have been reported