As of October 25, 2012, 328 cases of fungal meningitis have been reported to the CDC including 24 deaths in 18 states (the continuing status of this outbreak has been reported to you in Medical Risk Law Weekly News). These cases include incidences of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus peripheral joint infections (e.g., knee, hip, shoulder, or elbow). No deaths have been associated with the peripheral joint infections.
Laboratory-confirmed fungal meningitis is not contagious. The CDC’s laboratory has confirmed Exserohilum rostratum in clinical specimens. Patients have been found to be infected with Aspergillus fumigatus and with Cladosporium. These fungi are common in the environment but rarely cause meningitis.
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) in the implicated lots from New England Compounding 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 other implicated lots of methylprednisolone acetate and other NECC injectable medications continues.
The CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the implicated lots of methylprednisolone and nearly 97% have now been contacted for further follow-up.
The CDC continues to work with states to determine if there may be other fungal infections caused by exposure to NECC products beyond the implicated lots of preservative-free methylprednisolone acetate (80mg/ml) from NECC that were recalled on September 26, 2012.
The FDA advises medical professionals that all products produced by NECC should be retained, secured, and withheld from use. NECC recalled all of its products currently in circulation that were compounded at and distributed from its Framingham, Massachusetts, facility. The FDA further advises healthcare providers to follow-up with patients who were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution.
The FDA made available two lists of customers who received products that were shipped on or after May 21, 2012 from NECC’s facility in Framingham, Massachusetts. The first list includes customer names and addresses, organized by state. The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped, and the shipping date. The lists were prepared based on information provided by NECC, and the FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and facility information may be incomplete. Nevertheless, this is the best information available, at this time. The FDA provided the lists so that healthcare providers can focus their attention on following up with the patients who are believed to be at greatest risk of receiving a contaminated product.
Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. In this outbreak symptoms typically have appeared 1 to 4 weeks following injection, but it’s important to know that longer and shorter periods of time between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection.
See the CDC Report
See the CDC Case Count Map
See the FDA Update
See the Original Recall