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Crestor survives Public Citizen attack

Physician Practice Advisor, March 16, 2005

Drug manufacturer AstraZeneca received good news on Monday, when the Food and Drug Administration (FDA) rejected a petition from the advocacy group Public Citizen to remove the anti-cholesterol drug Crestor from the market.

According to USA Today, the FDA refused to withdraw the drug because they did not find enough hard evidence to support Public Citizen's assertion that Crestor could result in serious kidney damage for its users. The FDA's own study of adverse-event reports and other data concerning Crestor concluded that Crestor offered no more of a risk to users than other drugs in the statin class. Conversely, Public Citizen alleged, in its petition, that Crestor is linked to six times as many reports of muscle damage per million prescriptions as all other statins combined.

AstraZeneca officials and shareholders were relieved by the ruling, given
that sales of the popular Crestor topped $908 million worldwide in 2004.
Officials within Public Citizen, on the other hand, were disheartened by what they said is another in a series of disappointing decisions by the FDA.

"Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company instead of the public," wrote Sidney Wolfe, a medical doctor and director of Public Citizen's Health Research Group.

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