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 increase production and may consider foreign suppliers, Commissioner Margaret Hamburg said in a Web posting today. The drugs Westborough, Massachusetts-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 29 patients. Six Ameridose drugs were on the FDA’s drug shortages list, according to an FDA statement yesterday. No infections have been traced to Ameridose, which suspended operations 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.”
The FDA received additional powers in June from Congress to help mitigate shortages after a short supply of cancer drugs created an opening for dangerous unapproved versions to make it onto 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.
President Barack Obama directed the FDA a year ago to gather information from drugmakers about potential shortages so the government can respond before patients’ lives are threatened. The agency’s drug shortage office at the time staffed five employees. Congress passed legislation in June requiring drug manufacturers to notify FDA they may discontinue a product.
The 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 today, 404 infections in 19 states had been reported, including the 29 deaths, according to the Centers for Disease Control and Prevention.
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