Oct. 29, 2004

Rate of Kidney Damage in Crestor Patients Is 75 Times Higher Than in Patients Taking Other Cholesterol Drugs

Public Citizen Renews Call for Crestor to Be Removed From Market

WASHINGTON, D.C. – The rate of reports of kidney failure or damage among patients taking the cholesterol drug Crestor is 75 times higher than in all patients taking all other statins, according to a Public Citizen analysis of government data. Public Citizen sent the information today to the U.S. Food and Drug Administration and renewed its call for the drug to be taken off the market.

“It becomes clearer by the day that this drug is uniquely toxic but offers no unique benefit, and must be removed from the market,” wrote Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, to FDA Acting Commissioner Lester Crawford.

According to the analysis, the rate of reports to the FDA of acute renal failure or renal insufficiency per million prescriptions in patients using rosuvastatin (Crestor) – 29 U.S. reports in less than one year since the drug was first marketed in this country – is approximately 75 times higher than the rate for all other statin drugs combined.

The FDA had evidence before approving the cholesterol drug Crestor that it caused an increased incidence of rhabdomyolysis (severe muscle deterioration), yet the agency approved it anyway, erroneously believing that this toxicity was limited to an 80 milligram dose that was not ultimately approved. The drug went on the market in September 2003. In March 2004, Public Citizen petitioned the FDA to remove the drug from the market because it had been linked to muscle damage and kidney failure.

There have been 29 reported U.S. cases of acute renal failure or renal insufficiency out of 4.5 million Crestor prescriptions filled between September 2003 and the end of August 2004. For all other statins (including Lipitor, Zocor, Lescol, Pravachol and Mevacor), there have been 27 cases of acute renal failure or renal insufficiency reported from Jan. 1, 2001, through Sept. 30, 2003, out of 316 million prescriptions filled. This is a rate of .085 cases reported per million prescriptions filled.

Thus, the rate of reports of acute renal failure or renal insufficiency for Crestor is 6.4/.085, or 75 times higher than that of all of the other statins.  In addition, as of August 26, 2004, there had been 65 reports of rhabdomyolysis among U.S. patients taking Crestor, a rate of reports approaching that of Baycol, a cholesterol drug that was taken off the market because of rhabdomyolysis. To read Wolfe’s letter, go to http://www.worstpills.org.