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According to the Public Citizen consumer group, 29 patients taking AstraZeneca Plc''s statin drug Crestor have developed kidney damage. Public Citizen first issued an FDA petition in March 2004 for the immediate ban of Crestor in the U.S. After completing an analysis of the FDA''s adverse drug reaction database, finding the rate of reports to the FDA of acute renal failure or renal insufficiency per million prescriptions in patients using Crestor to be 75 times higher than the rate of all other statin drugs combined, the consumer group issued a renewal of its request for a Crestor ban.
An FDA medical officer first expressed concern of acute renal failure in the July 2003 FDA hearing preceding Crestor''s approval, but the agency approved the drug anyway. After just six months on the market, links to muscle damage and kidney failure led Public Citizen to issue its first petition. Dr. Sidney Wolfe, director of Public Citizen''s Health Research Group, recently renewed its call for a Crestor ban by issuing a letter to the FDA Acting Commissioner Lester Crawford saying, “it becomes clearer by the day that this drug is uniquely toxic but offers no unique benefit, and must be removed from the market.”