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Distributed via Health Alert NetworkOctober 8, 2012, 13:10 ET (1:10 PM ET)CDCHAN-00328-2012-10-08-ADV-N
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.
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.
On September 26, 2012, the NECC voluntarily recalled the following three lots of methylprednisolone acetate (PF) 80mg/ml:
All infections detected as of October 8 have occurred after injections with methylprednisolone acetate products from one of these lots. At this time, there is no evidence of infection related to other NECC products.
The FDA investigation into the NECC facility is ongoing. On October 5, FDA reported observing “fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from the New England Compounding Center.” Further analysis is ongoing. On October 6, NECC expanded its previous recalls to include all products currently in circulation that were compounded at and distributed from its facility in Framingham, Mass. More information about this recall is available at the FDA website.
*Case Definition (NOTE: the initial date for an epidural/joint steroid injection has been revised from July 1, 2012, to May 21, 2012).
1Clinically diagnosed meningitis meaning one or more of the following symptoms: headache, fever, stiff neck, or photophobia and a CSF profile consistent with meningitis (pleocytosis +/- low glucose, elevated protein).
2These people, if possible, should have a lumbar puncture.
3Clinically diagnosed septic arthritis meaning new or worsening pain with presence of effusion or new or worsening effusion.
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