Patient Notification Advised in Multistate Fungal Meningitis Outbreak ; Some Alaska Facilities Received Products
October 17, 2012
The FDA is advising health care facilities nationwide to contact patients who received any injectable drugs produced by NECC after May 21, 2012, and instruct them to contact a health care provider immediately if they experience any symptoms of fungal infection.
Symptoms of fungal infection may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from a surgical site; or headache, stiff neck, nausea and vomiting, sensitivity to light, and altered mental status. No action is necessary for persons who do not have symptoms.
The concern arises from the ongoing investigation of the New England Compounding Center (NECC) and the report of two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery. Aspergillus fumigatus is a fungal infection. Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.
The Alaska Department of Health and Social Services is aware of several health care facilities in Alaska that received drugs included in this new FDA precautionary follow-up recommendation. The Alaska Department of Health and Social Services has notified all of these facilities in Alaska of this updated information, and according to the DHSSm each facility plans to conduct patient follow-up this week either by phone or through the mail.
The Alaska facilities that received these newly identified products are: AA Pain Clinic, Alaska Center for Facial Plastic Surgery, Alaska Spine Center, Alaska Spine Institute Surgery Center, Alaska Surgery Center, and Alaska VA Healthcare System in Anchorage, and the Surgery Center of Fairbanks.
The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product. Nationwide, 15 states have reported a total of 214 invasive fungal infections, with 15 deaths. At this time the only product that has been definitively linked to the outbreak is NECC’s methylprednisolone acetate steroid. FDA has informed DHSS that none of the methylprednisolone acetate product was distributed to Alaska. There have been no identified cases in Alaska linked to this initial outbreak and the recall of this product on October 4, 2012.
Edited by Mary Kauffman, SitNews
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