Multistate outbreak of fungal infection associated with injection of methylprednisolone acetate solution from a single compounding pharmacy - United States, 2012

Abstract

On September 18, 2012, the Tennessee Department of Health was alerted by a clinician regarding a patient with culture-confirmed Aspergillus fumigatus meningitis diagnosed 46 days after epidural steroid injection at a Tennessee ambulatory surgical center. By September 27, the initial investigation, carried out by the Tennessee Department of Health in collaboration with CDC and the North Carolina Department of Health and Human Services, had identified an additional eight patients with clinically diagnosed, culture-negative meningitis: seven in Tennessee and one in North Carolina. All nine patients had received epidural steroid injection with preservative-free methylprednisolone acetate solution (MPA), compounded at New England Compounding Center (NECC) in Framingham, Massachusetts. All nine patients had received one or more injections from three lots of MPA (lot numbers 05212012@68; 06292012@26; and 08102012@51). As of October 10, a multistate investigation led by CDC in collaboration with state and local health departments and the Food and Drug Administration (FDA) had identified 137 cases and 12 deaths associated with this outbreak in 10 states. Active case-finding efforts and extensive investigation into medications and medication lot numbers received by patients have confirmed that, as of October 10, no cases were associated with other lots of MPA, nor were any associated with other NECC products. This report describes the ongoing investigation by CDC and state and local health departments, and includes important recommendations for physicians and patients.