Summary
The FDA has told AstraZaneca to pull its ads for Crestor, a popular cholesterol reducing drug, because they do not mention its risks of causing acute kidney failure or rhabdomyolysis, a life-threatening muscle disorder. The FDA has been carefully watching the the drug following its approval and have several concerns about its side effects. Though AstraZaneca denies the FDA's claims, they have stopped their advertisements.
Original source:
http://www.usatoday.com/news/health/2004-12-22-crestor-ad_x.htm
Details
The Food and Drug Administration has asked the maker of cholesterol-lowering medication Crestor to stop running an advertisement that makes "false or misleading" claims about the drug's safety.
The FDA's letter to AstraZeneca (AZN) was posted on the agency's Web site Wednesday.
The Food and Drug Administration says AstraZeneca made false and misleading claims about Crestor's safety in national advertisements last month.
"A medication can be more effective and just as safe."
FDA whistle-blower David Graham, in testimony before a Senate committee Nov. 18, named Crestor as one of five drugs that pose serious safety concerns.
Graham said Crestor is the only cholesterol-lowering medication, or statin, that causes acute kidney failure and carries a higher risk of rhabdomyolysis, a potentially life-threatening muscle disorder, than other statins.
In response to Graham's comments, AstraZeneca ran a large ad in national and regional publications, including The Wall Street Journal, The Washington Post, The New York Times and USA TODAY.
"The scientists at the FDA who are responsible for the approval and ongoing review of CRESTOR have, as recently as last Friday (Nov. 19), publicly confirmed that CRESTOR is safe and effective; and that the concerns that have been raised have no medical or scientific basis," the ad stated, citing the FDA Web site.
But in a letter to Mark Szewczak, director of promotional regulatory affairs at AstraZeneca, the FDA's Christine Hemler Smith said there is no such statement on the agency's Web site.
In that press release, Galson said, "The five specific drugs that Dr. Graham identified in his oral testimony are currently approved as safe and effective for use in the United States," but he says nothing about Graham's concerns having no medical or scientific basis.
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Wednesday, January 19, 2005
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