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FDA Warns AstraZeneca On Crestor Again

Mar 11, 2005 | AP

AstraZeneca PLC has received its second warning in four months from the U.S. Food and Drug Administration over what the agency says are misleading claims in its ads for cholesterol-lowering medicine Crestor.

The latest letter, which was received in the last few days, said claims that Crestor lowers cholesterol better than Pfizer Inc.'s market leading medicine Lipitor are misleading because it cherry picks results from a study comparing the two medicines.

The information was reported on Friday.

The ads, which feature Dr.-Suess-like rhymes, were taken off the market in December. A company spokeswoman said Friday AstraZeneca believed the statements were presented appropriately, but takes the letter very seriously.

Another spokeswoman Kelly Caldwell declined to comment if the company would resume the campaign.

The company received a letter from the FDA last December over print ads it ran which said the agency confirmed the safety and efficacy of Crestor. Those ads were a response to statements made by FDA official Dr. David Graham, who said that Crestor was one of five drugs that should either be taken off the market or have its sales severely restricted. It was a one-time ad campaign.

Consumer advocacy group Public Citizen has asked the FDA to take the drug off the market because it says it causes serious health problems, including rhabdomyolysis, a severe muscle weakness condition.

Earlier this month, Crestor labels added a warning that starter doses should be reduced in Asian-Americans and some other patients.

A clinical trial found that levels of Crestor in patients with Asian heritage were double those of Caucasians taking the same dose, increasing the chance of muscle damage.

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