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Overview: CDC continues to work closely with state public health departments on a multistate investigation of fungal meningitis and other infections among patients who received a methylprednisolone acetate injection prepared by the New England Compounding Center in Framingham, Mass. Although cases of fungal meningitis continue to be reported, CDC recently observed an increase in the number of patients presenting with evidence of other infections associated with contaminated steroid medication. These complications have occurred in patients with and without evidence of fungal meningitis.
Updates from government/regulatory agencies:
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are coordinating a multistate investigation of meningitis among patients who received epidural steroid injections (medication injected into the spine). Several of these patients have had strokes related to the meningitis. In several patients, the meningitis was found to be caused by a fungus that is common in the environment but rarely causes meningitis. This form of meningitis is not contagious.
This information is especially important for outpatient surgery centers, pain clinics, hospitals (particularly emergency, ICU, neurology, lab, infection prevention, epidemiology staff), and patients. Please distribute this information to your colleagues as a way to assist with case finding and to alert your networks to clinical recommendations and recalled products associated with this outbreak.
Follow updates by visiting the CDC website.
Visit this page of CDC’s website for information on CDC Emergency Communications System phone calls.
Read the CDC’s Health Advisory issued on December 20, 2012.
Read the CDC’s Health Advisory issued on December 3, 2012.
Read the CDC’s Health Advisory issued on November 20, 2012.
Read the CDC’s Health Advisory on the voluntary recall of all Ameridose medical products, issued on November 1, 2012.
Read the CDC’s Health Advisory on the contamination identified in additional medical products from New England Compounding Center, issued on November 1, 2012.
Read the CDC’s Health Advisory issued on October 17, 2012.
Read the CDC’s Health Advisory issued on October 8, 2012.
Read the CDC’s Health Advisory issued on October 4, 2012.
Additional information from CDC:
- Updated case counts
- Map of Healthcare Facilities that received lots of Methylprednisolone Acetate (PF) recalled from New England Compounding Center on September 26, 2012
- Instructions for clinical teams regarding diagnostic testing
- Interim treatment options for patients
As this outbreak is unfolding, the material above may be updated. New updates can be found on the CDC website: http://www.cdc.gov/hai/outbreaks/meningitis.html
New: November 1, 2012: Ameridose recalls all unexpired drugs in circulation
Due to concerns raised by the U.S. Food and Drug Administration (FDA) and the State of Massachusetts during preliminary inspections, Ameridose is voluntarily recalling all of its products currently in circulation. Ameridose, LLC, based in Westborough, MA shares management with the New England Compounding Center (NECC), which has been associated with the fungal meningitis outbreak.
FDA has provided this website for information on the outbreak.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
Read the MedWatch safety alert, including links to the FDA statement, Q&As, and list of recalled products.
FDA issued a MedWatch Safety Alert on October 15 advising clinicians to follow-up with patients who received an injectable NECC product, including any ophthalmic drug that is injectable or used in conjunction with eye surgery, and a cardioplegic solution purchased from or produced by NECC after May 21, 2012.
APIC MEMBER PLAYS A PIVOTAL ROLE IN MENINGITIS INVESTIGATION
APIC member Dr. Marion Kainer testified before the U.S. Senate Committee on Health, Education, Labor and Pensions on November 15 on the lessons learned from her team’s investigative efforts related to the nationwide fungal meningitis outbreak.
During a hearing which focused on the failure of state and federal level regulators to protect patients from harm, Dr. Kainer’s work as director of the Tennessee Department of Public Health Healthcare Associated Infections and Antimicrobial Resistance program was lauded as “a textbook case of how to do it right.” In her testimony, Dr. Kainer outlined a timeline of how the outbreak investigation unfolded and highlighted the importance of the very close relationships that had been built between the health department and infection preventionists in her state. She also pointed out the need for continued federal funding for programs at the Centers for Disease Control and Prevention that sharpened her investigative skills and provided the additional staff that made the Tennessee Department of Health’s outbreak response possible.
Detailed account of the timeline of how this outbreak unfolded – in Dr. Kainer’s testimony
Committee webpage with video of the hearing (Dr. Kainer’s testimony is at 2:32:28)