Health Canada, Nov 24, 2004
2004-58
November 24, 2004
Warning
Updated safety information regarding Crestor®
OTTAWA - Health Canada wishes to advise Canadians of
safety concerns about Crestor®, a cholesterol lowering drug, when used at
the highest recommended dosage of 40 mg daily. The risk of rhabdomyolysis
(muscle breakdown) may be increased at higher doses. Health Canada
recommends that all patients taking Crestor®, or any cholesterol lowering
drug, should be using the lowest dose that will meet their treatment
goal.
Health Canada is actively reviewing the safety profile associated with
rosuvastatin (Crestor®), particularly the 40 mg dose, and is in receipt of
additional safety information provided by its manufacturer, AstraZeneca
Canada Inc.
In June 2004, Health Canada posted a Public Advisory about an
association between Crestor and rhabdomyolysis, a rare but serious muscle
disorder. The same month, AstraZeneca Canada Inc. issued a Dear Healthcare
Professional Letter to advise Canadian healthcare professionals of this
information.
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, muscle tenderness, fever,
dark urine, nausea, and vomiting. In severe cases, rhabdomyolysis can
result in kidney failure and can be life-threatening.
Since June 2004, Health Canada has received a further 6 reports of
rhabdomyolysis in patients using Crestor® which are under assessment.
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.
The text in this article was prepared by Health Canada.