Health Canada advises consumers about important safety information on statins

Advisory
2005-77
July 12, 2005
For immediate release

OTTAWA - Health Canada is advising Canadians about important safety information for all cholesterol-lowering drugs known as statins. These medications include Lipitor (atorvastatin), Zocor (simvastatin), Mevacor (lovastatin), Lescol and Lescol XL (fluvastatin), Pravachol (pravastatin) and Crestor (rosuvastatin).

Some patients may have pre-existing medical conditions which might cause them to have a greater risk of developing muscle-related problems, including a serious condition called rhabdomyolysis (serious muscle damage), if patients are using Statin medications. Rare reports of rhabdomyolysis have been seen worldwide and in Canada with the use of these drugs.

Health Canada had requested that all manufacturers of these drugs include a warning and description of this risk in the safety information sheets for each drug. The updates to the safety information sheet are now complete.

Before taking a statin, patients should tell their doctor or pharmacist if they:

• are pregnant, intend to become pregnant, are breast-feeding or intend to breast-feed;
• have thyroid problems;
• regularly drink three or more alcoholic drinks daily;
• are taking other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate) or niacin;
• are taking other medications, including prescription, non-prescription and natural health products, as drug interactions are possible;
• have a family history of muscular disorders;
• had any past problems with the muscles (pain, tenderness), after using a statin;
• have kidney or liver problems;
• have diabetes;
• have undergone surgery or other tissue injury;
• do excessive physical exercise.

Patients are advised to contact their physician promptly if they experience any of the following while on statin therapy:

• muscle pain they cannot explain;
• muscle tenderness or muscle weakness;
• generalized weakness, especially if they do not feel well (i.e. fever or fatigue);
• brownish or discoloured urine.

Patients should continue to take their medication as prescribed and should contact their physician if they have any concerns.

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Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2988

Public Inquiries:
(613) 957-2991