Pharmaceutical Injuries - Crestor

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Crestor

The cholesterol drug Crestor is being relabeled to add a warning that starter doses should be reduced in Asian-Americans and some other patients. The changes to the label include results from a Phase 4 pharmacokinetic study in Asian-Americans and highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity, especially at the highest approved dose of 40 mg. At this time, the FDA is also making statements about the muscle and kidney safety of Crestor based on extensive review of available information.

The new label urges physicians to start Asian patients, those with severe kidney disease and patients taking cyclosporine at the lowest dose level.

Crestor (generic name: rosuvastatin calcium) 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 have developed kidney damage. Crestor has also been linked to the potenially fatal disease Rhabdomyolysis.

The rate of reported kidney problems is about 75 times higher with Crestor than with all other drugs in the same class combined, consumer group Public Citizen said. According to its analysis, there have been 6.4 reports of acute kidney failure or kidney damage for every 1 million Crestor prescriptions filled.

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

Crestor is in the popular family of cholesterol-lowering drugs called statins. Several years ago Baycol, another popular statin drug, was banned for its link to rhabdomyolysis.

Crestor Side Effects were Evident Prior to FDA Approval!

Crestor was approved in the U.S. in August 2003, based on review of an extensive clinical database involving approximately 12,000 patients. At that time, the FDA identified in the WARNINGS section of the product label those patients whose increased baseline risk for myopathy warranted more careful monitoring when prescribed Crestor. The U.S. approved labeling included a specific section titled, “Myopathy/Rhabdomyolysis”, which states that patients who are of advanced age, have hypothyroidism, and/or renal insufficiency should be considered to have a greater risk.

These studies also 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 occur even at those lower doses.

Crestor Has More Side Effects Than Other Statins

The widely used cholesterol-lowering drug Crestor has at least twice the incidence of side effects as other drugs in the statin family. On May 23, 2004 a new study detailed these findings.

The study was based on adverse reactions to statins reported to the Food and Drug Administration by patients and physicians at Tufts-New England Medical Center in Boston.

Most of those reports involved muscle damage, called rhabdomyolysis, and poor functioning of the kidneys.

FDA Public Health Advisory on Crestor
FDA Crestor Information & Risks
Crestor Home Page

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