PFPC Daily - March 6, 2005



Health Canada tells Asians using cholesterol drug Crestor to reduce

dosage



Canadian Press, March 05, 2005



TORONTO (CP) - Daily doses of the cholesterol drug Crestor should be

severely reduced for people of Asian descent and other patients

displaying risk factors for muscular problems, says Health Canada.



The warning comes just days after U.S. officials announced the drug

would be relabelled in that country.



The U.S. Food and Drug Administration said Wednesday that Crestor,

like other drugs in the category known as statins, can have the rare

side-effect of serious muscle damage.



On Friday, Health Canada said the highest recommended daily dose of

Crestor - 40 mgs - must not be used by patients exhibiting the

following:



-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.



Health Canada recommends that all patients taking Crestor use the

lowest dose possible to meet their treatment goals.



The agency also suggests a 5-mg starting dose for Asian patients,

those with serious kidney problems and patients who might have other

risk factors for muscle problems.



A clinical trial in the United States found that levels of Crestor in

Asian patients were double those of Caucasians taking the same dose,

increasing the chance of muscle damage.



The new U.S. label urges physicians to start Asian patients, those

with severe kidney disease and patients taking cyclosporine at 5 mg.