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FDA Moves to Block Ad for AstraZeneca Drug

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From Associated Press

The Food and Drug Administration is seeking to block an ad touting the safety of the cholesterol drug Crestor, calling the claims misleading.

The agency asked the drug maker, AstraZeneca, to “immediately cease the dissemination” of the ad.

AstraZeneca spokeswoman Emily Denney said that the ad ran for only a short time and that the FDA had been advised that it was no longer being used.

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“The ‘patient safety’ print ad makes false or misleading safety claims that minimize the risks associated with Crestor, thereby suggesting that Crestor is safer than has been demonstrated by substantial evidence or substantial clinical experience,” the FDA said in a letter dated Tuesday.

The advertisement in question appeared in the Washington Post on Nov. 23, prompting Dr. Sidney Wolfe of the consumer group Public Citizen to complain to the FDA. Wolfe has sought to have Crestor withdrawn because of its rate of liver problems.

In its complaint, the FDA took issue with claims that its scientists had confirmed that there was no basis for concerns about the safety of the drug.

But the FDA said that “recent public statements made by the agency contradict that conclusion.”

In trading Wednesday, AstraZeneca shares slid 81 cents to $35.88 on the New York Stock Exchange.

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