PFPC Daily - July 14, 2005

Health Canada issues advisory over statins

Canadian Press, July 12

OTTAWA — Some patients with underlying health conditions could be
at risk of serious side-effects from widely prescribed
cholesterol-lowering drugs known as statins, Health Canada advised
Tuesday.

The medications, which include Lipitor (atorvastatin), Zocor
(simvastatin), Mevacor (lovastatin), Lescol and Lescol XL
(fluvastatin), Pravachol (pravastatin) and Crestor (rosuvastatin),
put some patients with pre-existing medical conditions at greater
risk of muscle-related problems.

Of most concern is a condition called rhabdomyolysis, a form of
serious muscle damage. Rare reports of rhabdomyolysis have been seen
worldwide with the use of these drugs.

Earlier this year, Health Canada requested that the drugs'
manufacturers change their product safety information to outline the
potential for muscle damage in higher-risk patients.

"So doctors should already be aware about this, but Health Canada
wanted to ensure the public was informed as well,'' spokeswoman
Jirina Vlk said Tuesday from Ottawa.

The following warning and description of the risk has now been
included in the patient safety information sheet for each drug:

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

Are pregnant, intend to become pregnant, are breastfeeding or intend
to breastfeed.

Have thyroid problems.

Regularly drink three or more alcoholic beverages a day.

Take any other cholesterol-lowering medications, such as fibrates
(gemfibrozil, fenofibrate) or niacin.

Take other medications, including prescription, non-prescription and
natural health products, as drug interactions may occur.

Have a family history of muscular disorders.

Had past problems with muscles (pain, tenderness) after taking a
statin.

Have kidney or liver problems or diabetes.

Had surgery or other tissue injury.

Do excessive physical exercise.

Patients are advised to contact their doctor 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 not feeling well, including having
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.