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March 15th, 2005

"FDA rejects petition to ban Crestor"

The consumer advocacy group Public Citizen submitted a petition to the FDA a year ago asking the agency to immediately withdraw the anti-cholesterol drug Crestor, but the agency has denied its request.

Crestor belongs to a group of drugs called statins, which have all been linked to cases of rhabdomyolysis, a serious and potentially fatal muscle break down. In 2001, another statin, Bayer AG’s Baycol, was pulled from the market after being linked to more than 100 deaths, many of them the result of rhabdomyolysis.

Last November, an FDA scientist and whistleblower, Dr. David Graham, named five drugs he felt needed more scrutiny, including Crestor. Last week, Public Citizen supplemented its petition with additional Crestor data, saying the drug is linked to six times as many reports of muscle damage per million prescriptions than the combined total of all other statins.

Public Citizen is not the only group that believes Crestor poses serious safety concerns. Editorials in The Lancet, a British medical journal, have criticized Crestor manufacturer AstraZeneca’s marketing efforts. The FDA has sent the company two warning letters saying its Crestor ads were misleading.

The FDA said there is no convincing evidence to support the group’s request but said they would continue monitoring ongoing clinical trials and adverse event reports involving Crestor. The Public Citizen’s director, Sidney Wolfe, said he thinks the FDA will eventually be proven wrong about Crestor, like it had been with Baycol and diabetes drug Rezulin. In a statement, Wolfe said the FDA sided with the drug company, not the public “once again.”

Crestor is taken by millions of people to lower their cholesterol and reduce the chances of heart disease.