Lawyers Looking At Crestor Risks, In Spite of Company’s Claims to Safety

Touted as a “super statin,” Crestor is prescribed to treat high cholesterol and prevent cardivascular disease. The U.S. Food and Drug and Administration (FDA) issued approval for the drug in August 2003, and in the years since, there have been potentially fatal conditions linked as side effects of Crestor. According to recent research, the statin drug may increase the risk of heart problems, and lead to Crestor cardiomyopathy, which is a disease that makes it difficult for the heart to pump blood throughout the body. In some cases, this may result in the need for a heart transplant. Crestor (atorvastatin) was approved by the FDA in 2003 for the treatment of high cholesterol. It is a member of a class of cholesterol-

lowering drugs known as statins. The drug is a direct competitor for Pfizer’s Lipitor and has a 12% market share of the $21 billion U.S. statin industry.

In 2004, the nonprofit public interest group Public Citizen Health Research Group filed a citizen’s petition with the FDA to ban Crestor. The petition, urging for immediate Crestor recall, was addressed to the FDA Commissioner at the time, Dr. Mark McClellan, and signed by Public Citizen director Dr. Sidney M. Wolfe. The petition cited, among other things, the decisions by major U.S. health insurers and the Swedish government not to reimburse for Crestor as proof of the drug’s dangers. In March 2005, the FDA issued a response to Dr. Wolfe that denied the petition and indicated that Crestor posed no greater threat than other drugs like it. In a 2005 alert, the FDA said that “it does not appear that the risk [of rhabdomyolysis] is greater with Crestor than with other marketed statins.” A product label change about the potential side effect was mandated by the FDA, however.

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. Since 2005, the FDA has twice issued warnings that Crestor could cause heart, muscle and kidney problems. The complete results of the Saturn clinical trials will be released November 15 at the annual American Heart Association meeting.