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Fungal Infections Associated with Contaminated Steroid Injections
Carol A Kauffman1, Anurag N Malani2
1Division of Infectious Diseases, Department of Internal Medicine, Veterans Affairs Ann Arbor Healthcare System, University of Michigan Medical School, Ann Arbor, MI 48105.
Abstract:
In mid-September 2012, the largest healthcare-associated outbreak in U.S. history began. Before it was over, 751 patients were reported with fungal meningitis, stroke, spinal or paraspinal infection, or peripheral osteoarticular infection, and 64 (8.5%) died. Most patients had undergone epidural injection, and a few osteoarticular injection, of methylprednisolone acetate that had been manufactured at the New England Compounding Center (NECC). The offending pathogen in most cases was Exserohilum rostratum, a brown-black soil organism that previously was a rare cause of human infection. Three lots of methylprednisolone were contaminated with mold at NECC; the mold from unopened bottles of methylprednisolone was identical by whole-genome sequencing to the mold that was isolated from ill patients. Early cases manifested as meningitis, some patients suffered posterior circulation strokes, and later cases were more likely to present with localized infection at the injection site, including epidural abscess or phlegmon, vertebral diskitis or osteomyelitis, and arachnoiditis with intradural involvement of nerve roots. Many patients with spinal or paraspinal infection required surgical intervention. Recommendations for treatment evolved over the first few weeks of the outbreak. Initially, combination therapy with liposomal amphotericin B and voriconazole was recommended for all patients; later, combination therapy was recommended only for those who were most ill, and voriconazole monotherapy was recommended for most patients. Among those patients who continued antifungal therapy for at least 6 months, outcomes for most appeared to be successful, although a few patients remain on therapy.
Insights
A 2012 fungal meningitis outbreak linked to contaminated methylprednisolone caused 751 infections and 64 deaths. Exserohilum rostratum was the primary pathogen, highlighting risks in compounded medications.
Area of Science:
- Infectious Diseases
- Public Health
- Mycology
Background:
- The 2012 New England Compounding Center (NECC) outbreak was the largest healthcare-associated fungal infection event in U.S. history.
- It involved 751 patients with serious infections, including fungal meningitis and spinal osteomyelitis, resulting in 64 deaths.
- Contaminated methylprednisolone acetate injections were the source, primarily linked to the rare pathogen Exserohilum rostratum.
Purpose of the Study:
- To detail the epidemiology, clinical manifestations, and treatment outcomes of the 2012 NECC fungal outbreak.
- To identify the causative pathogen and its source.
- To inform public health responses and clinical management strategies for similar future events.
Main Methods:
- Retrospective analysis of patient data, including clinical presentations and outcomes.
- Microbiological investigation, including isolation and whole-genome sequencing of the causative mold.
- Review of treatment protocols and their evolution during the outbreak.
Main Results:
- 751 cases of fungal infection reported, with manifestations including meningitis, stroke, and localized spinal infections.
- Exserohilum rostratum identified as the primary pathogen, originating from contaminated methylprednisolone lots.
- Treatment strategies evolved, with prolonged antifungal therapy (≥6 months) showing successful outcomes for most patients.
Conclusions:
- The NECC outbreak underscores the critical need for stringent sterile compounding practices and regulatory oversight.
- Exserohilum rostratum can cause severe invasive infections, necessitating prompt diagnosis and targeted antifungal therapy.
- Effective management requires a multi-disciplinary approach, including surgical intervention and prolonged antifungal treatment.
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