CDC Probes New Outbreak Associated With Compounded Steroids

Abstract

PUBLIC HEALTH AUTHORITIES IN THE United States are investigating what appears to be a second outbreak of fungal infections associated with compounded steroid injections. The compounding pharmacy being investigated has recalled all lots of products that are intended to be sterile. Thesuspectedoutbreakhas spurreda multistate investigation by authorities fromtheUSFoodandDrugAdministration (FDA), the US Centers for Disease Control and Prevention (CDC), and localpublichealthauthorities fromIllinois, NorthCarolina,Florida, andTennessee. The investigation comes on the heels of an ongoing outbreak of fungal meningitis cases causedbycontaminatedsteroid injectionsproducedbyaMassachusettsbased compounding pharmacy that beganlastfallandthatcausedillnessinmore than 740 patients, killing 55 of them. On May 24, the FDA announced that it had received several reports of infections among patients who received methylprednisolone acetate injections compounded by the Main Street Family Pharmacy in Newbern, Tenn. (http: //1.usa.gov/13QsH4K). The agency advised clinicians not to use any sterile products produced by the pharmacy, and the pharmacy recalled all sterile products with a “use by” date on or before November 20, 2013. By May 30, the CDC reported that 20 cases of suspected infections associated with these products had been reported in 3 states (http://1.usa.gov /12mqOzc). Most of the patients have developed skin or soft tissue infections without a clear cause after receiving a methylprednisolone acetate injection, according to the CDC. No cases of meningitis had been reported at press time, but according to the FDA, at least 1 infection appeared to have a fungal cause. The suspect methylprednisolone injections were distributed in 17 states. The original fungal meningitis was identified inSeptember2012,whenpublic health officials linked cases of fungal meningitistocontaminatedlotsofmethylprednisolone acetate steroid injections produced by the New England Compounding Center (NECC) in Framingham, Mass. More than 13 000 patients werepotentiallyexposedviaspinal injectionsofthecontaminatedproducts.Cases of localizedinfectionsassociatedwiththe contaminated injectionshavecontinued to emerge over the past several months, leading the CDC to urge continued vigilance. Additionally, CDC scientists recently reported a case of fungal meningitis relapse in 1 patient who was exposed to contaminated steroids from the NECC (Smith RM et al. N Engl J Med. doi: 10.1056/NEJMc1306560 [published online May 29, 2013]). The 80-year-old man was treated with voriconazole for 4.5 months and discontinued therapy after the infection had apparently resolved.However, aboutamonth later, the man presented with headache and neck pain, an elevated white cell count, and a positive specimen for Exserohilum rostratum. The man’s physician resumed treatment with voriconazole. “Because Exserohilum rostratum meningitis is a new clinical entity, it is not known whether the current treatment guidance is sufficient,” noted the authors. “Some patients with central nervous system infection may require prolonged antifungal therapy owing to the chronic nature of fungal diseases and the difficulty in maintaining adequate drug concentrations in the cerebrospinal fluid.” Clinical guidance from the CDC is available at http://1.usa.gov/RdXGz1. news@JAMA From JAMA’s Daily News Site