Crestor Rhabdomyolysis Risks

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March 2nd, 2005

"Public Citizen calls FDA Crestor announcement an act of cowardice"

The FDA announced a revised drug labeling for the cholesterol-lowering drug Crestor would be added, warning of the serious muscle damage called rhabdomyolysis.

A clinical trial found levels of Crestor in Asian patients were double those of Caucasians taking the same dose, which increases the risk of rhabdomyolysis. Instead of responding in a “public health-positive manner” to Public Citizen’s March 2004 petition to ban Crestor from the market, the consumer group said the agency has instead announced minimal labeling changes, putting the drug companies before the public.

According to Public Citizen, in attempts to please both sides of the fence, the agency “has sided once again with its funders in the drug industry.” The group acknowledges the rate of rhabdomyolysis is not as high as now banned statin drug Baycol, but points out the Crestor rate is higher than other statins.

In addition, Crestor was the only statin that caused rhabdomyolysis at any dose in clinical trials prior to approval. Even though the cases had occurred at 80 mg, a dosage that was not approved, the majority of post-marketing cases of rhabdomyolysis have been occurring at 10 or 20 mg.

Since Public Citizen’s last supplement to its petition to ban Crestor in October 2004 based on adverse reaction reports through August 26, 2004, an additional 52 U.S. cases of life-threatening rhabdomyolysis was reported to the FDA. An additional 12 U.S. cases of kidney failure or impairment in people not having rhabdomyolysis was also reported to the agency up to the end of January 2005.

Crestor was first marketed in September 2003, and according to Public Citizen, a total of 117 cases of rhabdomyolysis and 41 cases of kidney failure have been reported in the U.S. Crestor is not approved in several countries, including Germany, Norway and Spain because of safety concerns.