The prescription drug Crestor, also known as rosuvastatin, is produced by AstraZeneca and is used to lower cholesterol levels and treat various lipid disorders. Crestor belongs to class of drugs called statins that are often prescribed to lower harmful cholesterol levels. Statins such as Crestor work by reducing the production of an enzyme which causes the liver to produce cholesterol. Other statin drugs include Mevacor, Pravacor, Zocor, Lescol or Lipitor.

Crestor was approved by the U.S. Food and Drug Administration in August 2003, after much delay due to safety concerns. Despite questions about safety about Crestor, AstraZeneca has aggressively marketed Crestor, spending over $1 billion to promote Crestor in its first year. The manufacturer has marketed Crestor as a "super statin", claiming that it lowers harmful cholesterol levels better than other competing statins.

Possible Crestor Rhabdomyolysis Link and Other Crestor Side Effects
During clinical trials, seven patients using Crestor developed the life threatening disease rhabdomyolysis. Rhabdomyolysis is a condition in which large numbers of skeletal muscle cells die, causing massive amounts of muscle proteins, myoglobin, to enter the bloodstream. The muscle proteins become trapped in the kidneys where they interfere with the kidneys' normal filtering process, leading to potentially fatal kidney damage and renal failure. Clinical trials of Crestor revealed the presence of muscle proteins and microscopic blood in the urine. In addition, damaged muscle cells release large amounts of potassium that may result in abnormal heart rhythms that can lead to heart attack.

Safety concerns prompted AstraZeneca to withdraw the 80 mg. dose of Crestor and many critics still express concern over the 40 mg. dose. In May 2004, AstraZeneca, wrote doctors in Britain urging them to start patients on a mere 10-milligram dose of Crestor because of concern about the muscle-destroying condition, rhabdomyolysis.

Another statin drug, Baycol was recalled in August 2001 after reports of over 100 deaths worldwide due to rhabdomyolysis.

Symptoms of Rhabdomyolysis include:

• Muscle pain (in specific muscles or throughout the body)
• Weakness
• Tenderness
• Fever
• Nausea or Vomiting
• Dark Urine

If you experience any of these symptoms or any other side effects you should consult your doctor.

Group Demands Crestor Recall
In March 2004, the consumer advocacy group, Public Citizen, called for the FDA to ban Crestor from the market. The director of Public Citizen's Health Research Group, Sidney Wolfe, stated the FDA has received reports of 11 cases of rhabdomyolysis in patients using Crestor since late February, on top of 14 previously known. The records also show that seven of the newest patients were taking the 10-mg dose of Crestor, nine of them required hospitalization, and at least five were under age 50. Dr. Wolfe added, "[reports rhabdomyolysis in Crestor patients] is beginning to go off the charts. This is up there with Baycol." Despite the reports, AstraZeneca continues to assert that crestor is safe.

FDA Issues Public Health Advisory for Crestor
On June 9, 2004, the U.S. Food & Drug Administration (FDA) issued a Public Health Advisory announcing Astra-Zeneca's release of a revised package insert for Crestor (rosuvastatin) for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to reports of spontaneous adverse events in patients taking Crestor. The revised insert warns that certain patient populations may be at an increased risk for serious muscle toxicity (myopathy/rhabdomyolysis) associated with Crestor use, especially at the highest approved dose of 40 mg.

These risk factors and many of the recommendations for how to minimize the risk of myopathy are already incorporated in the in the U.S. FDA approved insert, which alerts physicians of the need to carefully read the Crestor product label and follow the recommendations for starting doses, dose adjustments, and maximum daily doses to minimize the risk of myopathy in individual patients.

Also, the Public Health Advisory, citing the existing US insert information, warns that patients who are of advanced age (65 years), have hypothyroidism, and/or renal insufficiency should be considered to have a greater risk for developing myopathy or rhabdomyolysis while receiving a statin. Physicians are warned to prescribe Crestor with caution in these patients, particularly at higher doses, as the risk of myopathy increases with higher drug levels. In addition, the U.S. approved labeling for Crestor also warns that that increased risk of myopathy may exist in certain sub-populations of patients taking Crestor - for example, subgroups of Asians, and patients also using cyclosporine and gemfibrozil. Furthermore, Crestor labeling also cites the maximum recommended dose is limited to 10 mg daily in patients with severe renal impairment or who are also taking gemfibrozil.

The Public Health Advisory also states that the FDA is continuing to investigate and evaluate reports of of rhabdomyolysis in association with Crestor.

In November 2004, FDA David Graham, the Food and Drug Administration's associate director of drug safety, told a Senate committee that Crestor, is unsafe despite having received the FDA's approval. Graham's testimony is based on reports linking Crestor to kidney failure and potentially life-threatening muscle damage.

May 2005: Crestor has more than double the side effects of rival drugs
U.S. Researchers reported that cholesterol-lowering drug Crestor has more than double the side effects, including deaths, of rival statin drugs. The study found that the rate of adverse events among Crestor users in the study was 2.2 times higher than patients taking Zocor (simvastatin) and 6.8 times higher than patients taking Lipitor (atorvastatin). Serious side effects include muscle damage known as myopathy, including a severe form known as rhabdomyolysis; proteinuria or protein in the urine; nephropathy, a reduced ability of the kidneys to filter toxins from the blood; and kidney failure.

Despite the report, the American Heart association which published the study in its journal Circulation, said the drug was still generally safe if prescribed propery and that patients should not panic or stop taking the drug

Public Citizen, a consumer watchdog group, had submitted a petition to the FDA in March 2005 urging the FDA to ban the drug - the petition was rejected.