What is Crestor?
Crestor (rosuvastatin calcium) is a statin drug, a medicine that lowers "bad" cholesterol and triglycerides, and raises "good" cholesterol in the blood. Crestor is made by AstraZeneca Pharmaceuticals LP, and was approved by the U.S. Food and Drug Administration (FDA) in 2003.
Crestor is part of a treatment program that should include a low-fat diet and exercise. You should be placed on a standard lipid-lowering diet and an exercise routine before taking Crestor, and should continue these activities during treatment.
Crestor can be taken as a single dose at any time of day, with or without food. The dose range is 5 to 40 mg once daily. You should start on the lowest possible dose and never at 40 mg. After starting or changing your dose of Crestor, your lipid levels should be checked within 2 to 4 weeks and your dose adjusted as necessary.
Crestor FDA Alert
In March 2005, the FDA issued an alert stating that serious muscle damage has been reported in patients taking Crestor as well as other statin drugs. While there does not appear to be a greater risk with Crestor than with other marketed statin drugs, the labeling for Crestor is being revised to highlight important information on the safe use of Crestor, in order to reduce the risk for serious muscle damage, especially at the highest approved dose of 40 mg.
Additionally, the alert reported a study revealing that the amount of the drug in the blood of a diverse group of Asian patients taking Crestor was two times higher than for Caucasian patients in the study. The labeling for Crestor will now recommend a lower starting dose of 5 mg for Asian patients.
Kidney failure of various types has also been reported in patients treated with Crestor and other statin drugs. However, the FDA does not have enough evidence to conclude that kidney damage is a direct result of Crestor therapy.
Who Should Not Take Crestor?
You should not take Crestor if you:
- Have liver problems or have persistently high liver enzymes.
- Are pregnant or planning to become pregnant. Crestor may harm your unborn baby. If you become pregnant, stop taking Crestor and contact your healthcare professional immediately.
- Are breast-feeding. It is still unknown if Crestor can pass into breast milk and harm your baby. You should choose either to take Crestor or to breast-feed, but not both.
- Are allergic to Crestor or any of its ingredients.
Crestor has not been studied in children.
Crestor Health Risks
Crestor may cause rare, but serious, side effects including:
- Muscle Damage, which can lead to kidney damage. Crestor should be used with caution if you have kidney problems, advanced age, and hypothyroidism, because of the greater risk of muscle damage. Tell your healthcare professional if you develop unexplained muscle pain, tenderness, or weakness while on Crestor, particularly if accompanied by malaise or fever.
- Liver Damage. Your healthcare professional may do blood tests to check your liver before you start taking Crestor, and while you take it. Crestor should be used with caution if you have a history of liver disease or drink substantial amounts of alcohol.
Other side effects from Crestor use include:
- Muscle pain
- Abdominal pain
If you are taking Crestor or any other statin drug and develop signs and symptoms of muscle pain and weakness, fever, dark urine, nausea or vomiting, you should contact your healthcare professional immediately.
What Should I Tell My Healthcare Professional?
Before taking Crestor, you should tell your healthcare professional about all known medical conditions, including if you:
- Are pregnant or planning to become pregnant
- Are breast-feeding
- Have liver problems
- Have kidney problems
- Drink alcohol
Can Other Medicines or Food Affect Crestor?
Crestor and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take - including prescription and non-prescription medicines, vitamins, and herbal supplements.
You should be sure to tell your healthcare profession if you take:
- Cyclosporine (Gengraf, Neoral, Sandimmune)
- Warfarin (Coumadin)
- Gemfibrozil (Lopid)
- Drugs that may decrease the levels or activity of your body's own steroid hormones, including ketoconazole (Nizoral), spironolactone (Aldactone), and cimetidine (Tagamet)
- Aluminum and magnesium hydroxide combination antacids (e.g. Maalox)
Crestor - Getting Legal Help
While all medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."
If you or a loved one have experienced any dangerous symptoms or unusual medical conditions related to Crestor use, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Crestor use.
- Go here to learn more about an attorney's role in a pharmaceutical liability case.
- To find an experienced attorney, use the "Find a Lawyer" tool on this page, or click here.
Contact a qualified product liability attorney to make sure your rights are protected.