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Subscribe To Our Syndicated NewsCrestor considered riskier than other statin drugs
May 24, 2005
In March, the FDA concluded AstraZeneca's cholesterol-lowering drug Crestor did not carry greater risks than its competitors, allowing the drug to remain on store shelves. New research is challenging the FDA's earlier assertion, with data showing Crestor causes more kidney and muscle problems than rival medications.
The drug agency's decision against consumer efforts to issue a Crestor recall is being challenged by the new study, which is based on side effects reported to the FDA. According to the study published online yesterday by the American Heart Association's journal Circulation, kidney problems and muscle weakness were two to eight times more frequent among Crestor users than those taking other cholesterol-lowering drugs like Lipitor, Zocor and Pravachol.
FDA spokeswoman Laura Alvey said the new analysis showed no new information regarding Crestor risks, and the agency has not found any convincing evidence that the drug has a greater risk than other statins. After denying efforts to remove Crestor from the market back in March, the FDA ordered a warning on the drug's labeling saying Crestor could cause serious muscle problems and kidney damage, especially among Asians.
In the new Crestor study, researchers analyzed reports of side effects sent to the FDA, comparing Crestor to the rates during the same time period of three other statins - Lipitor, Zocor and Pravachol. The study's leader said that while the study indicated Crestor has a greater risk for adverse effects compared to other drugs in its family, the overall rate of side effects is still relatively low.
Crestor entered the market in 2003, and one year later, more than five million prescriptions were filled for the drug. Although AstraZeneca said the company strongly disagrees with the latest Crestor study results, Dr. Sidney Wolfe of the Public Citizen consumer group said the study is one more example of why Crestor should be removed. Wolfe said Public Citizen would try again to get a Crestor recall issued.For more information on Crestor warnings, please contact us to confer with a lawyer.
