FDA tracking down new outbreak tied to compounded drug
Call it FDA déjà vu. While Congress continues to spar with the FDA over its oversight of compounding pharmacies, agency officials are running down yet another outbreak of possible infections tied to a potentially contaminated steroid manufactured by a compounding pharmacy.
The agency said in an alert that there have been 7 reports of adverse reactions after patients received injections of preservative-free methylprednisolone acetate, manufactured by Main Street Family Pharmacy, a compounding pharmacy in Newbern, TN. That is the same drug at the heart of the fungal meningitis outbreak that began last year and at last count had sickened 741 people, 55 fatally. The FDA is still figuring out what has caused the recent reactions but told providers to quarantine the drug because it is a "potentially contaminated medication."
Read more: FDA tracking down new outbreak tied to compounded drug - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-tracking-down-new-outbreak-tied-compounded-drug/2013-05-28#ixzz2UgNxCZfZ
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