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Subscribe To Our Syndicated NewsFDA says Crestor ads are false or misleading
December 17, 2004
The FDA sent a letter dismissing a full-page ad published in newspapers for AstraZeneca's Crestor cholesterol-lowering drug saying it is "false and misleading" because serious concerns remain about the safety of the drug.
The FDA has been concerned with safety problems related to Crestor ever since it was approved because of the drug's effect on the kidneys. The agency said in the letter sent to AstraZeneca that they have been watching Crestor's effect on the kidneys "very carefully" ever since approval and believes the ads minimize the risks associated with the 40 mg dose of Crestor. In the ads it stated, "The FDA has confidence in the safety and efficacy of Crestor" and the agency "as recently as last Friday publicly confirmed that Crestor is safe and effective," which is untrue according to the FDA.
Just days before the Crestor ads ran, top officials were quoted as having concern about Crestor's safety. The FDA has sent out nine letters warning companies of false promotions since September, but the latest letter to AstraZeneca stands out. The FDA rarely criticizes a company for misrepresenting the agency.
Public Citizen consumer group has called for Crestor's withdrawal from the market and the director of the health research group, Dr. Sidney Wolfe, has predicted the company will be forced to withdraw the drug soon. An analysis by the group shows there were 29 reports of kidney failure or insufficiency among patients given Crestor in the first year of its U.S. approval. The limited number of prescriptions for Crestor makes the rate of kidney failure or insufficiency 75 times the rate for all other similar drugs combined, according to Public Citizen.
The Crestor ads ran in response to the widespread concern among patients and physicians about the drug in light of ongoing safety concerns. In the FDA letter sent to AstraZeneca's director of promotional regulatory affairs, the agency called the advertisement false and said "FDA is not aware of substantial evidence or substantial clinical experience demonstrating that all doses of Crestor are 'just as safe,'" as other cholesterol-lowering drugs.
AstraZeneca believed Crestor would be a lucrative drug and analysts had predicted sales would top $1 billion this year and reach $4.5 billion by 2007. In the first nine months of 2004, Crestor sales reached just $596 million.For more information on Crestor warnings, please contact us to confer with a lawyer.
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