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Rhabdomyolysis is a life threatening case of muscle fiber breakdown that results in the fibers entering circulation and its toxicity sometimes leading to kidney damage or failure. In August 2001, Baycol cholesterol-lowering drug was removed from the market and has since been linked to over 100 fatal instances of rhabdomyolysis. Now, Crestor cholesterol-lowering drug is being compared to Baycol after reports of rhabdomyolysis in Crestor using patients have been made.

Even before Crestor was approved, Public Citizen consumer group strongly urged the FDA not to allow it onto the market. Part of the class of drugs known as statins, Crestor is the only statin to have shown cases of life-threatening instances of rhabdomyolysis prior to approval. Even pre-approval studies for Baycol did not include a single case of rhabdomyolysis.

Despite the risks of rhabdomyolysis and serious effects, the FDA approved Crestor for the U.S. market in September 2003. In an October 2003 editorial in British medical journal The Lancet , the editor questioned AstraZeneca''s marketing tactics because of the "disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines." In March 2004, just weeks after a major Crestor direct-to-consumer advertising television campaigns was launched, Public Citizen consumer group petitioned the FDA for the immediate removal of Crestor.

The consumer group believed the major advertising launch made it especially crucial for the FDA to immediately act before more instances of rhabdomyolysis and serious adverse effects were suffered. Public Citizen included information in the petition that it had obtained from the FDA and health agencies in the U.K. and Canada that included seven cases of life-threatening rhabdomyolysis and nine cases of kidney failure or kidney damage in patients that were mostly using lower doses of Crestor. The only acceptable FDA response Public Citizen felt was appropriate to "show it has concern for patient safety, and not drug industry wishes, is to pull Crestor from the market immediately."

Just over five months on the U.S. market, Crestor was reported to cause the death of a 39-year-old woman after suffering rhabdomyolysis and renal insufficiency. The woman was on a 20 mg a day dose of Crestor. Patients taking doses of only 10 mg of Crestor have also reported suffering kidney problems. When Public Citizen initially voiced its concern regarding Crestor''s safety at a July 2003 FDA advisory committee meeting, the consumer group stated it was likely and maybe certain that a Crestor approval would eventually lead to a removal because of post-marketing cases of rhabdomyolysis and kidney failure that was inevitable.

AstraZeneca has already removed an 80 mg dose of Crestor because of safety concerns, yet some critics are still worried about the availability of the 40 mg dose. In pre-approval studies, the majority of patients on the 20 and 40 mg doses of Crestor that developed rhabdomyolysis were not on the drug for a sufficient period of time according to Public Citizen. The additional information gathered from the U.S., U.K., and Canadian governments documenting rhabdomyolysis cases and kidney damage only confirms the consumer group''s previous position on Crestor.

"Possible Crestor®-Heart Failure Link"

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

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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.

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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.

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