This is an official
CDC HEALTH ADVISORY
Distributed via Health Alert Network
October 8, 2012, 13:10 ET (1:10 PM ET)
CDCHAN-00328-2012-10-08-ADV-N
Update: Multistate Outbreak of Meningitis and Stroke Associated with Potentially Contaminated Steroid Medication
Summary
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) continue to work closely with state public health departments on a multistate investigation of fungal meningitis among patients who received an epidural steroid injection. Some of these patients also suffered strokes that may have resulted from their infection. These cases are associated with a potentially contaminated steroid medication prepared by New England Compounding Center (NECC), located in Framingham, Mass. This HAN notice provides updated information about the investigation (including a change in the case definition*), laboratory findings, an expanded voluntary recall of products, and recommendations for clinicians
Background
CDC, in collaboration with FDA, state public health departments, and state boards of pharmacy, has been investigating an ongoing outbreak of meningitis associated with a potentially contaminated steroid medication, preservative-free methylprednisolone acetate (80mg/ml) prepared by New England Compounding Center, located in Framingham, Mass. CDC and state public health departments are actively coordinating outreach to patients who have been exposed to this potentially contaminated medication.
As of October 8, 2012, a total of 105 cases, including 8 deaths, have been reported in 9 states: Florida (4 cases), Indiana (11 cases), Maryland (5 cases, including 1 death), Michigan (21 cases, including 2 deaths), Minnesota (3 cases), North Carolina (2 cases), Ohio (1 case), Tennessee (35 cases, including 4 deaths), and Virginia (23 cases, including 1 death). Fungus has been identified in specimens obtained from at least nine patients, one of whom also had Propionibacterium acnes, of unclear clinical significance, isolated from a post-mortem central nervous system specimen. In addition to an Aspergillus spp. isolated from a Tennessee patient, the fungus Exserohilum rostratum was identified in other patients, indicating the possibility of infections caused by multiple organisms. Fungal meningitis is not transmitted from person to person.
The clinical presentation of infected patients remains consistent with the prior report: onset of symptoms is typically 1 to 4 weeks following injection with a variety of symptoms, including fever, new or worsening headache, nausea, and new neurological deficit (consistent with deep brain stroke). Some of these patients’ symptoms were very mild in nature. Cerebrospinal fluid (CSF) obtained from these patients has typically shown elevated white cell count (with a predominance of neutrophils), low glucose, and elevated protein. As of October 8, no infections resulting from injection into a peripheral joint space have been reported.
Product Recall..
[link to emergency.cdc.gov]
