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Crestor Ads Draw Fire; FDA Could Act

Dec 8, 2004 | USA TODAY A House Democrat has asked the Food and Drug Administration to crack down on the maker of the cholesterol-lowering drug Crestor for what he calls misleading advertising on its Web site and in national newspapers.

Crestor is one of five drugs named as potentially hazardous by FDA drug safety officer David Graham in testimony to Congress. AstraZeneca, which manufactures and markets Crestor, responded with full-page advertisements in national and regional publications, including The Wall Street Journal, The Washington Post,The New York Times, and USA TODAY that said, "The FDA has confidence in the safety and efficacy of CRESTOR."

Rep. Henry Waxman, D-Calif., the ranking Democrat on the House Committee on Government Reform, said in a letter to the FDA on Friday that AstraZeneca's advertising conflicts with the FDA's public statements about the drug. He asked the FDA to review the company's statements and order them to post a correction if the statements are incorrect.

"Either AstraZeneca is misleading the public about Crestor's safety, or FDA officials are giving the company private assurances that conflict with the agency's public position," Waxman wrote. He said the company's statement on its Web site that it had been assured that senior-level FDA officials have "no concern in relation to Crestor's safety" appears to conflict with FDA statements.

Waxman pointed to one newspaper interview in which Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency "had been very concerned about Crestor since the day it was approved, and we've been watching it very carefully."

But Galson also said in a written statement following the congressional hearing that Graham's testimony didn't reflect the FDA's views and that all five of the drugs Graham mentioned are currently approved as "safe and effective" for use in the USA.

Waxman's letter echoes a similar letter sent in November by consumer activist group Public Citizen, which claims the drug is unsafe and should be banned from the market.

FDA spokeswoman Kathleen Quinn acknowledged the agency has received Waxman's letter. The FDA "takes his concerns seriously and will respond promptly," she said.

AstraZeneca stands by its advertising, spokeswoman Emily Denney said. "It is consistent with what has been communicated to us by the FDA," she said. She said the ad, which ran for two or three days, was essential to correct misinformation that emerged during the congressional testimony. She said the company was deluged with calls from doctors and patients.

Crestor, approved in August 2003, is a "statin" drug prescribed to lower cholesterol levels. The FDA issued a health advisory this year after AstraZeneca changed the label on Crestor for the European Union to include a warning about the risk of developing a muscle problem called rhabdomyolysis. Although the U.S. label already noted the risk, the FDA said it would alert physicians to be especially careful when prescribing the drug.

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