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Meningitis probe could hit hospital drug supplies - FDA

Source: Thomson Reuters Foundation - Mon, 22 Oct 2012 19:54 GMT
Author: Reuters
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By Bill Berkrot

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 as the number of infection cases neared 300, 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 shuttered 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 23 deaths.

Twelve additional fungal meningitis cases were reported on Monday, bringing the total to 294 in 16 states, plus three cases of peripheral joint infection likely linked to the tainted steroid, but no new deaths, according to U.S. Centers for Disease Control and Prevention.

Nine of the new cases were reported in Michigan - one of the hardest hit states - with two more in Indiana and one in Maryland, the CDC said. Michigan so far has reported 63 infections and five deaths. Tennessee has been hardest hit with 69 reported cases and nine deaths.

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.

Although the typical incubation period for contracting fungal meningitis from the tainted steroid is one to four weeks after injection, it can be far longer. Doctors have been cautioned to monitor patients for signs of meningitis for several months after they received injections.

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