Fungal Infections Associated with Contaminated Methylprednisolone Injections
This article demonstrates the need for FDA oversight of all medications and how our response to a potential public health crisis can be rapidly and effectively mobilized for the common good.
Fungal infections are rare complications of injections for treatment of chronic pain. In September 2012, an investigation was initiated into fungal infections associated with injections of preservative-free methylprednisolone acetate that was purchased from a single compounding pharmacy. The following, published in the New England Journal of Medicine (2013;369:1598-1609), summarizes the findings.
As part of the investigation, three lots of methylprednisolone acetate were recalled by the pharmacy and fungus was observed as part the examination of unopened vials. Following this observation, notification of all persons potentially exposed to this formulation of methylprednisolone acetate was conducted by federal, state, and local public health officials and by staff at clinical facilities that administered the drug. The authors collected clinical data on standardized case-report forms, and tested for the presence of fungi in isolates and specimens by examining cultures and performing polymerase-chain-reaction assays and histopathological and immunohistochemical testing.
Results showed that by October 19, 2012, more than 99% of 13,534 potentially exposed persons had been contacted. As of July 1, 2013, there were 749 reported cases of infection in 20 states, with 61 deaths (8%). Other morbidities included 40 patients (5%) with stroke Laboratory evidence of Exserohilum rostratum was present in specimens from 153 case patients (20%). Additional data were available for 728 case patients (97%); 229 of these patients (31%) had meningitis with no other documented infection. Case patients had received a median of 1 injection (range, 1 to 6) of implicated methylprednisolone acetate. The median age of the patients was 64 years (range, 15 to 97), and the median incubation period (the number of days from the last injection to the date of the first diagnosis) was 47 days (range, 0 to 249).
According to the authors, analysis of data from a large, multistate outbreak of fungal infections showed substantial morbidity and mortality. The infections were associated with injection of a contaminated glucocorticoid medication from a single compounding pharmacy. Rapid public health actions included prompt recall of the implicated product, notification of exposed persons, and early outreach to clinicians.