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Fungal meningitis from contaminated steroid infects 105 people across nine states, eight deaths

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SafetyShare® newsletter brought to you by the Premier Safety Institute ®
1/15/2013
Gina Pugliese, RN, MS, editor


SafetyShare®

Multistate outbreak of fungal meningitis from contaminated steroid


Health Alert NetworkOn October 8, 2012, CDC issued an Official Health Advisory distributed by the Health Alert Network
(HAN):

Update on the multistate outbreak of meningitis and stroke associated with potentially contaminated steroid medication.
This issue of Safety Share summarizes that update.

As of January 15, 2013: 678 cases in 19 states with 44 deaths.

See ongoing updates from CDC and FDA:

http://www.cdc.gov/hai/outbreaks/meningitis.html

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 (NECC), 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
eight deaths, have been reported in nine states (FL, IN, MD, MI, MN NC, OH, TN and VA). Fungus has been
identified in specimens from numerous patients, including Aspergillus spp and Exserohilum rostratum, indicating the possibility of 
infections caused by multiple organisms. Fungal meningitis is not transmitted from person to person.

Clinical presentation

The 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 patients’ symptoms were very mild in nature. Cerebrospinal fluid (CSF) 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

On September 26, 2012, three lots of methylprednisolone acetate (PF) 80mg/ml were recalled by NECC:

  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012
  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
  • Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

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.

Recommendations

 

Additional Information



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