FDA criticizes misleading Crestor ads; refuses recall

The U.S. Food and Drug Administration’s (FDA) has refused the request of a consumer rights group to recall Crestor. Readers might recall that world-famous FDA scientist Dr. David Graham has put Crestor in the same category as Vioxx - drugs that are simply too dangerous to be on the market since the FDA does not fully understand their risks.

Crestor is a member of a class of cholesterol-lowering drugs commonly referred to as 'statins' and was approved in the U.S. in August 2003. Earlier this month FDA issued only a health advisory against Crestor to re-emphasize recommendations made in the original label about the need for physicians to consider using lower starting doses of the drug in some individuals as a means of reducing the risk of rhabdomyolysis (serious muscle damage). The drug is particularly dangerous for people of Asian origin.

Last week, FDA also warned the Crestor manufacturer AstraZeneca to immediately cease misleading advertisements for Crestor charging that a TV ad and the “STELLAR” print ads make false or misleading claims regarding the superiority of Crestor. The agency says that Crestor's "comparison with Lipitor is misleading because it suggests that Crestor is superior to Lipitor when in fact none of the approved doses of Crestor was significantly superior to 80 mg of Lipitor in the STELLAR study."

Sidney Wolfe, Director of Public Citizen’s Health Research Group criticized FDA's action saying that the agency has once again sided with the drug industry rather than the American people. Senator Chuck Grassley who is working to shake up the agency has accused Merck of manipulating FDA in the Vioxx case since FDA at no point tried to make American people aware of the dangers of Vioxx. Dr. Wolfe in a statement says that "This response should give no comfort to either physicians or patients who are using or considering using Crestor." He mentions Baycol, Rezulin, and Vioxx as examples of drugs that FDA knew were dangerous but left them on the market to keep the drugmakers pleased. In a recent case, FDA refused to recall Adderall and even tried to pressure Health Canada not to do so. Adderall is still available in the United States. (Related article: FDA must recall Adderall till sufficient safety data is available)

Dr. Wolfe is expecting that science will eventually show that Crestor is indeed a drug that is not safe. "Once again, when faced with concerns about the safety of a drug, the FDA has sided with the drug company, AstraZeneca, instead of the public. When Crestor is taken off the market, if not before, this will represent yet another blow to the agency’s badly tarnished reputation," he says.

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