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Defective Drug Side Effects Topics
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Crestor (rosuvastatin) was FDA approved in August 2003 as a cholesterol-lowering drug. Lowering the "bad" cholesterol and triglycerides and raising "good" cholesterol in the blood, Crestor was intended as part of a treatment program that should also include a low-fat diet and exercise. The approval of Crestor was initially delayed for about a year after the FDA expressed concern over Crestor side effects when taking using 80-milligram doses. When FDA approval of Crestor was granted, the agency concluded it was safe for use at doses up to 40-milligrams.
On Crestor labeling, there are warnings about the potential for muscle and kidney problems, but the Public Citizen consumer group does not feel warning labels are adequate action for the dangers Crestor poses. On March 4, 2004, not even a year after FDA approval, Public Citizen called on the FDA to immediately remove Crestor from the market. The petition was prompted after a 39-year old woman using Crestor died from kidney damage caused by a rare muscle destroying disease called rhabdomyolysis.
In addition, two other U.S. Crestor using patients have suffered rhabdomyolysis and data from the U.S., the UK, and Canada show seven cases of rhabdomyolysis and nine cases of kidney damage or failure has occurred after FDA approval. According to the Public Citizen press release, in studies before the Crestor approval, seven people suffered rhabdomyolysis. In its petition, the Public Citizen noted the Crestor side effects were suffered with doses between 10 and 40 milligrams. The rare muscle damaging disease that can lead to kidney failure and death has been tied to other statins and was the reason for the 2001 Baycol recall.
The Public Citizen believes Crestor's pre-approval clinical trials showed signs of being more dangerous than Baycol, which did not indicate life-threatening instances of rhabdomyolysis. Even before the FDA approved Crestor, Public Citizen strongly urged the FDA not to after seeing the risks of muscle and kidney damage that could occur with its use. In addition, there appeared to be a lack of evidence showing Crestor reduces the risk of heart attacks and strokes, as well as to lower cholesterol levels.
Marketed by AstraZeneca, Crestor's toxicity is far greater than other statins on the market. The director of Public Citizen thinks that Crestor's dangers is distinguished from other statin risks because it is the only one on the market linked to kidney problems not caused by rhabdomyolysis. AstraZeneca has continued to claim that the drug risks of Crestor are the same as other statins on the market and blames the consumer group's protests against Crestor as the reason the drug's approval was delayed a year to begin with.
The group has been actively warning consumers about the dangerous drugs on the market since 1996, including six drugs that were taken off the market. There have been over two million Crestor prescriptions written despite having "no unique advantages over other statins," according to Public Citizen director Sidney Wolfe.
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