Crestor

On the market for only 5 months, the Public Citizen consumer group has asked the FDA to immediately ban Crestor from the market.

Seven patients using this cholesterol-lowering drug (rosuvastatin), have developed life-threatening muscle deterioration (rhabdomyolysis), and nine others have suffered kidney failure or damage. A 39 year old woman died even though she was taking Crestor at an approved dosage. Crestor doesn't seem to reduce the risk of heart attacks and strokes as well as lower cholesterol unlike some other statins.

Rhabdomyolysis occurs when a large number of skeletal muscle cells die, releasing a massive amount of muscle protein into the bloodstream. This protein can become trapped in the kidneys and lead to kidney failure. Also, potassium released from the damaged muscle cells can, in rare cases, cause malignant heart rhythms resulting in heart failure.

Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. If you are taking Crestor and are experiencing any of these symptoms, ask your doctor for a blood test called CK or CPK, which will determine if you are suffering from rhabdomyolysis.

Crestor is a registered mark of AstraZeneca. AstraZeneca's application to market Crestor (rosuvastatin) was delayed when the FDA asked for more data about the company halting clinical trials worldwide after learning of kidney damage and muscle weakness (an early signal for rhabdomyolysis) in patients taking 80 milligrams of Crestor per day. They stopped development of the 80 milligram dose because of the safety problems, and Crestor (rosuvastatin) will only be sold in 5, 10, 20, and 40 milligram strengths.

The 80-milligram dose of Crestor was not be approved because of serious side effects including muscle and kidney damage and it was feared the drug would produce side effects even at lower doses.

In the FDA review documents posted on the agency's web site it was noted "In contrast to currently approved statins, rosuvastatin was also associated with renal [kidney] findings not previously reported with other statins."

The risk of muscle damage leading to rhabdomyolysis during treatment with Crestor may be increased when it is used together with other cholesterol lowering drugs and cyclosporine (NEORAL, SANDIMMUNE), a drug used after transplantation to prevent organ rejection.

AstraZeneca remains adamant that Crestor is no more dangerous than any other cholesterol medications. The FDA asserts that there has been no evidence that Crestor has the same problems associated with Baycol, which was withdrawn from the market in 2001 after it was linked with patient deaths.

In an October 2003 article the Health Research Group argued AstraZeneca failed to prove Crestor resulted in any health benefit. It also expressed deep concern that Crestor was the only statin to cause rhabdomyolysis in clinical trials.