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.
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.
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