Advisory: Health Canada, possible association between Crestor® and rhabdomyolysis

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http://www.hc-sc.gc.ca/english/protection/warnings/2004/2004_34.htm

 

 

2004-34

June 21, 2004

For immediate release

AdvisoryHealth Canada Is advising Canadians about a possible association between

Crestor® and rhabdomyolysis

OTTAWA -Health Canada is advising Canadians about a possible association between

the cholesterol lowering drug Crestor®, and a serious condition called

rhabdomyolysis.

 

Rhabdomyolysis is a condition that 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 result in kidney failure and can be

life-threatening.

 

Rhabdomyolysis has also been reported with other cholesterol lowering drugs in

the " statin " family. " Statins " are a specific type of cholesterol lowering

medication. Between February 2003 and June 2004 there have been eight cases of

rhabdomyolysis reported in Canadian patients taking Crestor®. In five of those

cases the patients were taking the maximum recommended dose (40 mg) of the drug,

in two cases the patients were taking the lowest recommended starting dosage (10

mg) and in the remaining case, the dosage was not stated. All of the Canadian

reported cases were associated with predisposing risk factors, and no deaths

have been reported.

 

There are certain factors that might cause an individual to have a greater risk

of developing muscle related problems, including rhabdomyolysis, if they are

taking a statin. These factors include: kidney problems, an underactive thyroid

gland, alcohol abuse, a past history of significant muscle pain or significant

muscle weakness while on statin therapy, a personal or family history of

inherited muscle problems, and Japanese or Chinese ethnicity. The risk is also

increased for patients who may be taking other medications which might interact

with statins. Health Canada recommends that all patients taking Crestor® consult

with their doctors to determine if any of these factors apply to them.

 

Because the risk of rhabdomyolysis is increased at higher doses, Health Canada

recommends that all patients taking Crestor®, or any cholesterol lowering drug,

should be on the lowest dose that will meet their treatment goal.

 

All patients taking Crestor®, or any cholesterol lowering drug, are advised to

report any unexplained muscle pain, muscle weakness or cramps, or any brown or

discoloured urine, to their physician immediately.

 

This advisory is in addition to a letter issued by the manufacturers of

Crestor®, following consultation with Health Canada, to health care

professionals reminding them of the above mentioned safety concerns.

 

If you have questions regarding your current prescription, please contact your

physician or pharmacist. Any suspected adve

 

rse drug reactions in patients receiving Crestor® can 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

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html

 

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be

found on the Health Canada web site or in The Canadian Compendium of

Pharmaceuticals and Specialties.

 

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html

http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html

 

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Media Inquiries:

Jirina Vlk

Health Canada

(613) 957-2988

 

Public Inquiries:

(613) 957-2991