In August 2003, the Food and Drug Administration (FDA) approved Crestor (rosuvastatin) to lower cholesterol. Lowering cholesterol is a key to reducing the risk of heart disease. Crestor is in the class of drugs called HMG-CoA reductase inhibitors, also known as statins. These drugs work by partially blocking the synthesis of cholesterol in the liver which leads to increased removal of cholesterol from the blood. Statin drugs should be prescribed along with a low-cholesterol diet and an exercise program. They lower levels of bad cholesterol (LDL-C) and triglycerides (TG) and increase levels of good cholesterol (HDL-C) in the blood. The higher the level of LDL-C in the blood, and the lower the level of HDL-C, the greater the risk for coronary artery disease, or atherosclerosis, which develops because of accumulation of cholesterol in the walls of arteries. In addition, other factors, such as high blood pressure
, and a family history of early heart attack
also increase the risk of atherosclerosis.
The most frequent side effects seen in patients treated with Crestor include muscle aches
, stomach pain
, and weakness. In rare instances, severe muscle pain and muscle weakness resulting in kidney damage
have been associated with statin drugs. If general muscle aches persist, patients should call their physician.In March 2004, the consumer advocacy group Public Citizen called for the FDA to ban Crestor, citing three cases of kidney failure or life-threatening muscle damage (rhabdomyolysis), including one death, among patients taking recommended dosages of the drug. The group also noted that Canada and the United Kingdom have reported seven additional cases of rhabdomyolysis and nine additional cases of kidney damage or failure. Public Citizen also contends that AstraZeneca intentionally delayed reporting side effects to the FDA.
Patients should be monitored for liver function abnormalities before treatment, at 12 weeks following initial therapy and after any dose elevation. Monitoring is recommended periodically thereafter.
Crestor is available in 5, 10, 20, and 40 mg tablets. The medication is marketed by AstraZeneca.
In June 2004, FDA issued a Public Health Advisory notifying healthcare professionals of a revised package insert for use in the 22 member states of the European Union (EU). The changes to the European labeling are in response to adverse event reports in patients receiving Crestor and highlight certain patient populations who may be at an increased risk for serious muscle toxicity (myopathy) 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 captured in the FDA approved labeling for Crestor in the U.S. FDA alerted physicians 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.
A study published in the May 2005 edition of the American Heart Association's journal Circulation revealed that kidney problems and muscle weakness were two to eight times more frequent among Crestor users than those taking other cholesterol-lowering drugs such as Lipitor and Zocor. The study analyzed reports of Crestor side effects sent to the FDA and compared them to similar reports sent for other statins.
See your doctor if you have experienced serious health problems after taking Crestor. In addition, it may be important to contact a lawyer
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.Attorneys associated with InjuryBoard.com
will evaluate your case free of charge
. In addition, you will not pay any fees unless your attorney recovers money for you. Please click on the free Ask An Attorney
button to take advantage of this valuable service.
- Cholesterol Drugs: Overview
- Digestive Disorders: Overview
- Joints & Muscles: Overview
- Kidney & Urinary Tract Disorders
- Kidney Failure
- Nausea: Overview
- Severe Constipation: Overview