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The number of adverse event reports involving muscle problems with the cholesterol drug Crestor outnumbered reports associated with other statins, according to the findings of a new study.
Research conducted by AdverseEvents, Inc. (PDF), a company that has developed a new method of analyzing the FDA’s Adverse Event Reporting System (AERS) data, suggests that Crestor may put users at a higher risk of suffering myopathy, rhabdomyolysis and other muscle problems, when compared to similar cholesterol medications.
Statins are already known to increase the risk of muscle problems, including the rare condition rhabdomyolysis, which causes muscle fibers to begin to break down and could lead to kidney failure or death. Although some scientific literature has suggested that the drugs share similar muscle related safety profiles, this new study suggests that may not be the case in large consumer populations.
According to the analysis, using a system called RxFilter, more than 150,000 muscle-related adverse events were reported to the FDA between January 1, 2004 and March 31, 2011, and included reports for Crestor, Lipitor, Zocor, Pravachol, Mevacor and Lescol, as well as generic and foreign equivalents. Crestor had the highest percent risk of muscle injury in six different categories, even after the company adjusted for possible stimulated reporting bias.
Researchers at AdverseEvents, Inc. suggested that they were surprised to find that Crestor side effects were the ones most likely to be linked to reports of muscle problems, as the drug is generally regarded as very safe.
Crestor (rosuvastatin) was approved by the FDA in 2003. The FDA has twice issued warnings that Crestor could cause heart, muscle and kidney problems.
In 2005, the non-profit consumer advocacy group, Public Citizen, filed a petition with the FDA calling for a Crestor recall to be issued due to the potential risk of health problems with Crestor and because there appear to be safer alternatives on the market. The FDA has not heeded the request, and Crestor has not been removed from the market.
In recent months, a growing number of product liability lawyers have begun reviewing Crestor lawsuits for individuals throughout the United States who developed heart problems like cardiomyopathy, diabetes and other injuries that may have been caused by side effects of Crestor.
Earlier this year, at the annual convention for the American Association for Justice, a Crestor litigation group was formed by a group of lawyers representing plaintiffs, so that they could meet and coordinate strategy against AstraZeneca regarding the possible cardiomyopathy lawsuits over Crestor.