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Updated: May 15, 2026
Microbiological Rapid On-Site Evaluation for Pulmonary Infectious Diseases
Published on: March 1, 2024
Fungal infections associated with contaminated methylprednisolone injections
Rachel M Smith1, Melissa K Schaefer, Marion A Kainer
1From the Epidemic Intelligence Service, Scientific Education and Professional Development Program Office (R.M.S., S.G., A.P.), Division of Foodborne, Waterborne, and Environmental Diseases (R.M.S., A.P., A.A.C., K.B., J.R.H., M.E.B., B.J.P.), Division of Healthcare Quality Promotion (M.K.S., M.W., J.J., J.T.W.), and Division of High-Consequence Pathogens and Pathology (D.B.), Centers for Disease Control and Prevention, Atlanta; the Tennessee Department of Health, Nashville (M.A.K., A.D.W.); the Michigan Department of Community Health, Bureau of Epidemiology, Lansing (J. Finks, J. Fiedler); the Indiana State Department of Health, Indianapolis (J.D., C.F.); the Virginia Department of Health, Richmond (E.F., L.G.); the Maryland Department of Health and Mental Hygiene, Baltimore (A.C.); the New Jersey Department of Health, Trenton (B.C.); the Florida Department of Health, Tallahassee (A.R.); and the North Carolina Division of Public Health, Raleigh (S.G.).
Background:
Fungal infections are rare complications of injections for treatment of chronic pain. In September 2012, we initiated an investigation into fungal infections associated with injections of preservative-free methylprednisolone acetate that was purchased from a single compounding pharmacy.
Methods:
Three lots of methylprednisolone acetate were recalled by the pharmacy; examination of unopened vials later revealed fungus. Notification of all persons potentially exposed to implicated methylprednisolone acetate was conducted by federal, state, and local public health officials and by staff at clinical facilities that administered the drug. We collected clinical data on standardized case-report forms, and we 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:
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%). 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); 40 patients (5%) had a stroke.
Conclusions:
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.
Insights
A fungal outbreak linked to contaminated methylprednisolone acetate injections caused significant illness and death. Public health officials responded rapidly to recall the drug and notify exposed individuals.
Area of Science:
- Infectious Diseases
- Epidemiology
- Public Health
Background:
- Fungal infections are rare complications following injections for chronic pain management.
- An investigation was launched into fungal infections linked to preservative-free methylprednisolone acetate from a single compounding pharmacy.
Purpose of the Study:
- To investigate a multistate outbreak of fungal infections.
- To identify the source and extent of contamination.
- To analyze the clinical outcomes and public health response.
Main Methods:
- Recalled three lots of methylprednisolone acetate; examined unopened vials for fungal contamination.
- Notified potentially exposed individuals nationwide.
- Collected clinical data and performed laboratory tests (cultures, PCR, histopathology) on patient specimens.
Main Results:
- 749 cases of fungal infection and 61 deaths reported across 20 states.
- Exserohilum rostratum identified in 20% of case patients.
- 31% of patients had meningitis; 5% experienced a stroke, with a median incubation period of 47 days.
Conclusions:
- A large, multistate outbreak of fungal infections resulted in significant morbidity and mortality.
- The outbreak was traced to contaminated glucocorticoid medication from a compounding pharmacy.
- Prompt public health interventions, including product recall and notification, were crucial.
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