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.