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FDA called to immediately remove Crestor from the market

March 4, 2004

Crestor cholesterol-lowering drug (rosuvastatin), marketed by AstraZeneca, should never have been FDA approved according to the Public Citizen consumer group that has called on the FDA to immediately ban the drug from the market. Approved just over five months ago, seven patients using the approved doses of Crestor developed life-threatening muscle deterioration, or rhabdomyolysis, and nine suffered kidney failure or damage. One U.S. Crestor patient died of kidney failure and rhabdomyolysis.

Rhabdomyolysis is muscle damage, which is the side effect that resulted in the Baycol recall in 2001, another statin cholesterol-lowering drug. When compared to Baycol, Public Citizen finds that Crestor may have had more indication of its dangers during pre-approval clinical trials.

Even before Crestor was approved, Public Citizen strongly urged the FDA in July 2003 not to approve Crestor after seven people were shown to suffer rhabdomyolysis in studies. Crestor also failed to show evidence of reducing the risk of heart attacks and strokes, as well as to lower cholesterol levels, which has been displayed with three other statins already on the market, according to the consumer group.

So far, over 1 million patients have taken Crestor. Public Citizen finds the number of problems to have occurred in less than a year to be "worrisome" and believes the only acceptable action for the FDA to show concern for patient safety is to immediately remove Crestor from the market.

"Possible Crestor®-Heart Failure Link"

Some researchers believe the cholesterol medication Crestor® (rosuvastatin) can increase the severity of heart failure in certain patients.

Coenzyme Q10 (CoQ10), pro...

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"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 ...

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"Asians taking Crestor may be at higher risk for rhabdomyolysis"

The FDA has announced that Crestor is being relabeled to add a warning that starter doses should be reduced in Asian-American patients, as well as some other higher risk patients.

A clinical trial found that levels in Asian patients were d...

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