Reuters: Regulatory News: FDA says meningitis probe could hit hospital drug supplies

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FDA says meningitis probe could hit hospital drug supplies Oct 22nd 2012, 18:42 By Bill Berkrot Mon Oct 22, 2012 2:42pm EDT Oct 22 (Reuters) - The extended shutdown of a sister company of the pharmacy at the center of the deadly U.S. meningitis outbreak may exacerbate drug shortages for some hospitals and healthcare providers, U.S. health regulators said. Ameridose, a drug manufacturer owned by the same people who own New England Compounding Center (NECC), has been closed since Oct. 10 and will remain closed until Nov. 5, while authorities complete an inspection of the plant as a precautionary measure - at least temporarily cutting off supplies to its customers. NECC shipped thousands of potentially contaminated vials of a steroid used for injections to treat severe back pain. Some 14,000 patients may have been exposed to the medicine that has so far led to more than 280 cases of fungal meningitis and 23 deaths across 16 states. All NECC products have been recalled, but no Ameridose products have been linked to meningitis or faced recall. The U.S. Food and Drug Administration posted a statement on its website on Saturday that said "the current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems." The agency said it was working with Ameridose to ensure that its drugs are safe. It directed hospitals and clinics to its drug shortage website for information on the availability of drugs currently in short supply. The FDA did not identify what drugs or healthcare systems were being affected by the lack of Ameridose products. Both NECC and Ameridose are based in Boston suburbs. NECC is facing federal and state investigations about whether it violated compounding pharmacy regulations by supplying large orders of medicines without matching its drugs to specific prescriptions for patients or treatment regimens. It is also facing a raft of lawsuits connected to the meningitis outbreak. Link this Share this Digg this Email Reprints

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