Femto Medicine - Part 6294

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Meningitis-Related Pharmacy Recall Worsens Drug Shortage

Posted: Published on November 3rd, 2012

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 FDAs 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 … Continue reading →

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Closure of Ameridose, sister company of pharmacy in meningitis outbreak, extended 2 weeks

Posted: Published on November 3rd, 2012

By Kay Lazar, Globe Staff A Westborough pharmacy and drug manufacturer with the same owners as the Framingham specialty phamacy at the center of the national fungal meningitis outbreak will remain closed until at least Nov. 19. The temporary closure of Ameridose LLC, by mutual agreement with state regulators Friday, was extended two weeks to give investigators more time to complete an inspection of the facility, after the company recalled its products this week. The Massachusetts Hospital Association released a statement saying the continued shutdown of Ameridose, which supplies more than 3,000 hospitals nationwide, heightens Massachusetts hospitals concerns about the possibility of prolonged and serious shortages of important medications. Ameridose had been scheduled to reopen Monday, but this past Wednesday it agreed to recall all its products after federal investigators identified shortcomings in its safety testing. The company acted on the recommendation of the US Food and Drug Administration but said it issued the recall voluntarily and had not received any reports of illness. A letter dated Friday and signed by the president of the Board of Registration in Pharmacy and a lawyer for Ameridose states that the board finds it necessary to extend the Agreement to conduct a comprehensive … Continue reading →

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