Archived – Health Canada advises patients about the risks of CRESTOR® (rosuvastatin)

Starting date:

March 3, 2005

Posting date:

March 3, 2005

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Important Safety Information

Audience:

General Public

Identification number:

RA-11000373

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Health Canada is advising Canadians about important safety information for CRESTOR^® (rosuvastatin). A recent U.S. 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

If you have questions about your CRESTOR^® (rosuvastatin) prescription, you should contact your doctor.

The manufacturer of CRESTOR^® (rosuvastatin), AstraZeneca Canada Inc., is working in collaboration with Health Canada to issue a letter to Canadian health care professionals discussing this information within the next two weeks. The Canadian Product Monograph for CRESTOR^® (rosuvastatin) has been updated to include this new safety information.

Past advisories of safety information about CRESTOR^®

Health Canada will continue to monitor the safety profile of CRESTOR^® (rosuvastatin), and will examine new safety information as it emerges. If you have had a serious or unexpected adverse reaction while taking CRESTOR^® you are invited to notify Health Canada as follows:

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: 613-957-0337 or Fax: 613-957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866-234-2345

Fax: 866-678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialities.

 

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