Meningitis-related pharmacy recall may worsen drug shortage


WASHINGTON — The recall of hundreds of drugs by Ameridose LLC, a compounding pharmacy associated with the U.S. meningitis outbreak, may be exacerbating shortages of medicines used for surgery and heart failure, regulators said.

The Food and Drug Administration is working with other manufacturers to ramp up production and may consider foreign suppliers, Commissioner Margaret Hamburg said in a Web posting today.

The drugs Westborough, Mass.-based Ameridose made were already in short supply and include local anesthesias, muscle relaxers to prevent movement during surgery and high-dose diuretics to remove fluids during congestive heart failure.

Ameridose said Oct. 31 it recalled all its products because of sterility concerns that arose after tainted drugs from New England Compounding Pharmacy Inc., a company controlled by the same people as Ameridose, were linked to meningitis infections that have killed 28 patients.

Six Ameridose drugs were on the FDA’s drug shortages list, according to statement yesterday.

No infections have been linked to drugs from Ameridose, which shut down operations on Oct. 10.

“We have doubled the number of staff members who work in drug shortage prevention and response,” Hamburg said.

“We at FDA are committed to doing everything we can, using all available tools, to prevent or mitigate drug shortages and help keep critically needed products on the market.”

In 2011, total drugs in short supply hit 251, Hamburg said. This year through September, the agency worked with drug manufacturers to help avert 145 shortages.

The fungal meningitis outbreak became known in late September, and regulators have linked the infections to contaminated steroids that were injected into about 14,000 patients to relieve neck and back pain. As of Thursday, 386 infections in 19 states had been reported, including the 28 deaths, according to the Centers for Disease Control and Prevention.


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