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drug_recall crestorCrestor cholesterol lowering medication has received some bad press recently. The latest drug in the class of statins, Crestor was just released in the U.S. in September 2003. By March 2004, Public Citizen consumer group petitioned the FDA to immediately remove Crestor from the market because of safety concerns, including Crestor deaths reported after life-threatening instances of rhabdomyolysis developed. Rhabdomyolysis is a condition that breaks down the muscle cells and releases them into the bloodstream, resulting in toxic effects to the kidney.
According to the consumer group, the FDA should have never approved Crestor with evidence of serious and potentially deadly effects shown in studies before its approval. In July 2003, the group strongly urged the FDA not to approve Crestor because of the muscle and kidney damage risks in addition to the failure of Crestor to show effectiveness in decreasing risk of suffering heart attacks, strokes, and lowering cholesterol levels. At the time of the FDA petition, Public Citizen claimed Crestor had been linked to around two-dozen instances of rhabdomyolysis and kidney failure or damage, including a Crestor death of a 39 year-old woman because of kidney damage and rhabdomyolysis.
The data used in the Public Citizen report was obtained from the U.S., the U.K., and Canadian governments and noted seven cases of rhabdomyolysis and nine cases of kidney damage or failure occurring in patients using Crestor following FDA approval. Crestor maker AstraZeneca continues to defend Crestor''s safety and responded to the Public Citizen''s claims as being "misleading". This stance differs greatly from the consumer group that believes the only way the FDA can indicate it believes in patient safety is to "pull Crestor from the market immediately."
Crestor has been compared to Baycol cholesterol-lowering drug, which was removed from the market in August 2001. Baycol is linked to at least 100 fatal cases of rhabdomyolysis and a high number of lawsuits. Sales for Crestor were below analysts'' expectations in 2002, and in early 2004, two major U.S. health insurers and the Swedish government announced it would not reimburse patients using Crestor. Still, AstraZeneca has recently told analysts it is hoping to capture 20 percent of the $22 billion a year statin market.
Public Citizen''s petition came just after AstraZeneca had launched major Crestor direct-to-consumer television ad campaigns. Referring to Crestor as a "super statin", AstraZeneca believes Crestor is the most potent of all statins currently in the market. The high exposure Crestor would attain because of the advertising made it especially urgent for the FDA to consider the removal petition according to Public Citizen.
Included in the petition was reference to an October 25, 2003 editorial in The Lancet in which the editor found AstraZeneca''s marketing approach for Crestor to "raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patient from inadequately investigated medicines." Over one million patients have been treated with Crestor, with over two million Crestor prescriptions having been distributed worldwide.
The consumer advocacy group Public Citizen submitted a petition to the FDA a year ago asking the agency to immediately withdraw the anti-cholesterol drug Crestor, but the agency has denied its request.
Crestor belongs to a group of drugs ...
The FDA has announced that Crestor is being relabeled to add a warning that starter doses should be reduced in Asian-American patients, as well as some other higher risk patients.
A clinical trial found that levels in Asian patients were d...
The FDA announced a revised drug labeling for the cholesterol-lowering drug Crestor would be added, warning of the serious muscle damage called rhabdomyolysis.
A clinical trial found levels of Crestor in Asian patients were double those of C...