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Crestor

In August 2003, after a delay because of safety concerns, the Food and Drug Administration (FDA) approved Crestor (generic name: rosuvastatin calcium), the latest of six cholesterol-reducing drugs called statins. The pre-approval studies linked Crestor with cases of kidney abnormalities not seen with other statins. The FDA decided to approve Crestor but at lower dosages. However, records from the FDA and health agencies in Canada and Britain show life-threatening side effects may occur even at those lower doses.

Crestor is approved as an adjunct therapy accompanied by a low-cholesterol diet and exercise program to reduce the overall level of bad cholesterol in the blood stream. It was also touted for raising levels of high-density lipoprotein cholesterol (HDL-C)—good cholesterol—in many cases.

Crestor has been linked to kidney damage and kidney failure. On October 22, 2004, the consumer group Public Citizen said twenty-nine patients who took AstraZeneca's cholesterol drug Crestor had developed kidney damage. Crestor has also been linked to the potenially fatal disease rhabdomyolysis.

According to Public Citizen, the rate of reported kidney problems is about 75 times higher with Crestor than with all other drugs in the same class combined. According to its analysis, there have been 6.4 reports of acute kidney failure or kidney damage for every one million Crestor prescriptions filled.

Crestor has been linked to numerous cases of rhabdomyolysis, a rare muscle-destroying disease. Another statin cholestrol drug, Baycol, was removed from the market for its link to rhabdomyolysis..

Crestor has been relabeled to add a warning that starter doses should be reduced in patients of Asian descent and some other patients. A clinical trial found that levels of Crestor in Asian patients were double those of Caucasians taking the same dose, increasing the chance of muscle damage. The new label urges physicians to start Asian patients, patients with severe kidney disease, and patients taking cyclosporine at the lowest dose level.
  ©2008 Kabateck Brown Kellner LLP, All Rights Reserved.