viernes, 12 de octubre de 2012

Drug Safety and Availability > FDA Statement on Fungal Meningitis Outbreak

Drug Safety and Availability > FDA Statement on Fungal Meningitis Outbreak

FDA Statement on Fungal Meningitis Outbreak

[UPDATE: 10-12-2012] FDA is continuing to actively investigate this situation.  It is our goal to contain the health risk as quickly as possible.  FDA considers this to be one of our top priorities and we are dedicating  many resources to this investigation. 
As part of the ongoing FDA investigation, FDA has confirmed the presence of a fungal contaminant in multiple sealed vials of methylprednisolone acetate injection, made by the New England Compounding Center’s (NECC) Framingham, Massachusetts site and from samples collected around the country.
FDA, in partnership with CDC, is in the process of attempting to identify the exact species of fungus isolated from the sealed vials and whether the fungus is the same as one of the two fungal organisms found in patients.
As part of the ongoing investigation, FDA’s investigators have collected samples of materials from the NECC facility in Framingham, Massachusetts, and from clinical facilities around the country that reported ill patients and/or had retained quantities of methylprednisolone acetate compounded by NECC. FDA is also reviewing the processes, procedures, and documentation at the facility.
Given the preliminary findings of the investigation of NECC, as a precaution, FDA urges patients who believe they received an injection or other product compounded by NECC to remain vigilant for the signs and symptoms of infection, including meningitis. The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Clinics, doctors' offices, and hospitals who used NECC products should advise concerned patients that have been given NECC products to seek medical care upon the onset of symptoms of infection.
Based on the business relationship between NECC and Ameridose, FDA and the Massachusetts Board of Pharmacy launched a joint inspection at the Ameridose facility in Westborough, Massachusetts on October 10, 2012. As part of our efforts to protect the public health, FDA is investigating whether certain aspects of compounding practices and facility conditions observed at NECC may be present at the Ameridose facility. FDA will review whether Ameridose has procedures and facilities necessary to safely produce and provide sterile drug products. At this time, there is no known contamination of products produced by Ameridose.
Users should also notify FDA of any complaints or problems associated with these products.  These reports may be made to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088 or on line at


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Page Last Updated: 10/12/2012

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