Statin drugs

Elaine Carry - Medical Reporter
Toronto Star

Wednesday, July 13, 2005

Statins, the popular cholesterol-lowering drugs used by more than 3 million Canadians every day, can lead to serious muscle damage in some patients, Health Canada is now warning.

The makers of all the drugs, which include Lipitor, Zocor, Pravacol, Mevacor and Crestor, must include a warning and description of the risk in patient safety-information sheets, the department said yesterday.

The drugs can cause muscle pain and lead to a serious potentially fatal muscle-wasting disease called rhabdmomyolysis in patients with certain pre-existing medical conditions.

A Toronto Star series last December, called "A Drugged Nation" detailed the controversy around statins, the world's fastest-growing class of drugs.

Health Canada said then statin-related rhabdomyolysis was "very rare," concerning in fewer than one in 10,000 patients.

A US Food and Drug Administration study last year found Raycol triggered the potential muscle disease 10 times more often than Lipitor, Zocor and Pravachol, although its maker, Bayer Inc., disputes the findings. (Baycol was pulled off the market in August 2001)

While downplaying the risks last December, Health Canada now says because so many people are using the drugs, it wants to make sure everyone is aware of the potential hazards.

The warning is a "precautionary measure,"> said Health Canada spokesperson, Jirina Vik, who noted the change to the drugs' packaging has been in place since May 3. "There's a high number of Canadians prescribed statins, so we want them to be aware of the risks associated with that," Vik said

But people shouldn't be alarmed by the warning says Dr. Alan Barolet, a cardiologist at Mount Sinai Hospital. "The shouldn't be made to be afraid of these drugs because they are overly, clearly beneficial."

The risk of developing rhabdomyolysis is small compared to the number of patients taking the drug, he said, adding that many who develop the disease often have pre-existing conditions or are taking other medications with the statins.

The wide-ranging warning tells patients to consult their doctor or pharmacist if they are pregnant or breast-feeding, have thyroid problems, drink three or more alcoholic drinks daily, or are taking other cholesterol-lowering medications such as fibrates or niacin.

Other risk factors include taking medications or natural health products because drug interactions are possible, having any past problems with muscle pain after taking a statin, having kidney or liver problems or diabetes; undergoing surgery or other tissue injury, or doing "excessive" physical exercise.

An analysis of the Canadian adverse drug-reaction database shows a statin was suspected as the cause of 1,739 adverse event reports filed between 1988 and 2003. Of those, 1,024 were considered serious.

Rice Bran Oil would support the reduction of cholesterol with natural botanical oils from seeds. They have no side effects or interfere with other drugs taken for the health issue in question.

The above information is provided for general educational purposes only. It is not intended to replace competent health care advice received from a knowledgeable healthcare professional. You are urged to seek healthcare advice for the treatment of any illness or disease.
Health Canada and the FDA (USA) have not evaluated these statements. This product is not intended to diagnose, treat, cure, or prevent any disease.

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