Food and Drug Administration whistle-blower David Graham isn't giving up.
He's not content with helping to keep Merck's drug Arcoxia (the son or daughter Vioxx, depending upon who you read) off just the U.S. market, because that still leaves 63 countries in which the arthritis medication is sold.
Graham, of the agency's Office of Surveillance and Epidemiology, warned an FDA advisory panel Thursday that Arcoxia would be "a potential public-health disaster" because it raises heart attack and stroke risk. The panel voted 20 to 1 against recommending approval of Arcoxia, which critics have likened to Vioxx, the arthritis drug Merck withdrew in September 2004 because of cardiovascular safety concerns.
The FDA typically follows the advice of its advisory panels.
Graham said Friday that he wants to figure out how many extra strokes and heart attacks may have occurred in Europe since Arcoxia went on the market there in 2004. "I'm hoping that in Europe they reconsider this drug," he said. "It's clearly killing people."
More from Rita Rubin in USA Today
Graham, of the agency's Office of Surveillance and Epidemiology, warned an FDA advisory panel Thursday that Arcoxia would be "a potential public-health disaster" because it raises heart attack and stroke risk. The panel voted 20 to 1 against recommending approval of Arcoxia, which critics have likened to Vioxx, the arthritis drug Merck withdrew in September 2004 because of cardiovascular safety concerns.
The FDA typically follows the advice of its advisory panels.
Graham said Friday that he wants to figure out how many extra strokes and heart attacks may have occurred in Europe since Arcoxia went on the market there in 2004. "I'm hoping that in Europe they reconsider this drug," he said. "It's clearly killing people."
More from Rita Rubin in USA Today
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