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Safety
Problems Associated with
Of the approved statins, cerivastatin (BAYCOL), was removed from the market because of at least 31 reports of fatal rhabdomyolysis, an adverse reaction involving the destruction of muscle tissue that can lead to kidney failure. AstraZeneca originally filed its application with the FDA to market rosuvastatin in June 2001. The application was delayed when the company halted clinical trials worldwide after reports of kidney damage and muscle weakness (an early signal for rhabdomyolysis) in clinical trials in patients taking 80 milligrams of the drug per day and the FDA asked AstraZeneca for more data. The company stopped development of the 80 milligram dose because of the safety problems, and rosuvastatin will only be sold in 5, 10, 20, and 40 milligram strengths. On July 9, 2003 Public Citizen petitioned the FDA to withhold approval of rosuvastatin because of its unique potential to cause kidney toxicity. In the FDA review documents posted on the agency's web site before the Endocrinologic and Metabolic Drugs Advisory Committee it was noted "In contrast to currently approved statins, rosuvastatin was also associated with renal [kidney] findings not previously reported with other statins." If you or a loved one believe they have been harmed by Crestor, we can help. When it comes to dangerous drugs, Fonvielle Lewis Foote and Messer represents clients throughout the United States. We can assist you wherever you live. For more information, please call us at (800) 876-7773 or print, complete and mail the CRESTOR Questionnaire Crestor Information on the Web:
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