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NECC-New England Compounding Center-Potentially Contaminated Medication: Fungal Meningitis Outbreak

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Posted 10/7/2012 9:02 PM (GMT 0)
From the CDC email that I get:
" FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from New England Compounding Center (NECC). FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus."

"Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time."

"Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, FDA is advising not to use it at this time. This includes all products compounded and distributed at NECC; not just the ones that have been recalled. Please see the CDC website for additional information.


Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
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, incliding links to the FDA statement, Q&As, and list of recalled products, at:

www.fda.gov/Safety/Recalls/ucm322901.htm?source=govdelivery
Posted 10/12/2012 2:26 AM (GMT 0)
Update:
"As of October 5, a total of 47 cases* in 7 states and 5 deaths have been identified with a clinical picture consistent with fungal infection: Florida (2 cases), Indiana (3 cases), Maryland (2 cases, including 1 death), Michigan (4 cases), North Carolina (1 case), Tennessee (29 cases, including 3 deaths), and Virginia (6 cases, including 1 death). Fungus has been identified in specimens obtained from 9 patients, including Aspergillus and Exserohilum.

"All patients who may have received these medications need to be tracked down immediately. Patients can find the names of the clinics that used these medications on the CDC website," said Benjamin Park, M.D., medical officer, Mycotic Diseases Branch, CDC. "It is possible that if patients with infection are identified soon and put on appropriate antifungal therapy, lives may be saved."

Infected patients have developed a variety of symptoms approximately 1 to 4 weeks following their injection, 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 obtained from these patients has shown findings consistent with meningitis."

"Patients who have had an epidural steroid injection since May 21, 2012, and have any of the following symptoms, should talk to their doctor as soon as possible.

Worsening headache
Fever
Sensitivity to light
Stiff neck
New weakness or numbness in any part of your body
Slurred speech"

"The 23 states where the contaminated product was shipped are California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia. For a list of all of the facilities who have received contaminated product" -
please copy and paste this link into your browser window: http://www.cdc.gov/hai/outbreaks/meningitis-facilities-map.html

Thanks to "Science Daily" for the update.
www.sciencedaily.com/releases/2012/10/121007190851.htm?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+sciencedaily+%28ScienceDaily%3A+Latest+Science+News%29
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