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Health Canada Advises Patients Ab Risks of CRESTOout TheR (rosuvastatin)

Mar 3, 2005 | Health Canada

Health Canada is advising Canadians about important safety information for CRESTOR (rosuvastatin). A recent US study has found that Asian patients may be at greater risk of developing muscle-related adverse events with this drug. CRESTOR is a cholesterol-lowering drug in the "statin" family. "Statins" are a specific type of cholesterol-lowering medication.

In Canada, and internationally, CRESTOR has been associated with reports of a serious condition called rhabdomyolysis. Rhabdomyolysis results in muscle breakdown and the release of muscle cell contents into the bloodstream.

Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, fever, dark urine, nausea, and vomiting. In severe cases, rhabdomyolysis can lead to kidney failure and be life-threatening.

For some patients, there may be pre-existing conditions or other personal factors that could cause a greater risk of developing muscle-related problems, including rhabdomyolysis, if they are using "statin" medications.

The risk of rhabdomyolysis is increased at the highest recommended daily dose of CRESTOR, which is 40 mg daily. For this reason, Health Canada has advised that the 40 mg dose must not be used in patients who have pre-existing medical conditions or other factors which put them at increased risk for rhabdomyolysis. These factors include:

Personal or family history of muscle problems
Past history of significant muscle pain or muscle weakness while using a "statin" drug
Taking any other cholesterol-lowering medications
Serious liver problems
An underactive thyroid gland
Alcohol abuse
Asian ethnicity

Asian patients (having either Filipino, Chinese, Japanese, Korean, Vietnamese or South Asian origin) may be at greater risk of developing muscle-related adverse events, including rhabdomyolysis, with CRESTOR(rosuvastatin). In a recent U.S. study, levels of rosuvastatin were found to be approximately two times greater in Asian-Americans when compared to a Caucasian control group.

Health Canada recommends that all patients taking CRESTOR® should be using the lowest dose that will meet their treatment goal. A 5 mg starting dose is recommended for:

Asian patients
Patients with serious kidney problems
Patients who might have other risk factors for muscle problems

Health Canada continues to monitor the use of CRESTOR(rosuvastatin) for a possible association with kidney failure, and will update Canadians as further information becomes available.

In addition, Health Canada has asked all manufacturers of "statin" drugs to update the information in the Canadian Product Monographs to enhance the safe and effective use of this group of cholesterol-lowering medications. The new information will include the medical conditions and other factors that might cause a patient to have an increased risk of muscle-related adverse reactions to "statin" medications. The new information will also provide patients with more information about the safe use of "statin" drugs. The medical conditions and other factors which might cause a patient to be at greater risk of muscle related adverse reactions to "statin" medications include:

Personal or family history of muscular problems

Previous history of muscle problems with another "statin"

Use of other cholesterol medications
Underactive thyroid gland
Alcohol abuse
Excessive physical exercise
Aged 70 years or over
Kidney problems
Liver problems
Diabetes with fat deposits in the liver
Surgeries or injuries
Frail physical condition

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