The Accutane, Acne, Rosacea Controversy

Health Canada is investigating reports of strokes and heart attacks in people taking Accutane, the controversial acne drug that causes birth defects and has been linked to psychiatric problems.

Twenty-nine cases of patients who developed a vascular disorder after taking isotretinoin, the generic name for Accutane, have been reported since the drug was approved in Canada in 1983.

Eleven involved strokes, blood clots or a heart attack, none of which are labelled as possible reactions in the drug's prescribing information.

The patients ranged in age from 15 to 48.

One 18-year-old with no known risk factors suffered a stroke two months after starting the drug.

"Health care professionals are encouraged to report any cases of myocardial infarction, cerebrovascular and thromboembolic disorders suspected of being associated with isotretinoin," a new Health Canada report on adverse drug reactions says.

Isotretinoin's use is expected to grow as cheaper generic versions reach the market.

A spokesman for Health Canada stressed there is no evidence Accutane caused the rare reports of stroke and blood clots in users.

They are based on suspicions only and could be due to some underlying illness. Some of the patients had risk factors for stroke, such as high blood pressure or obesity. In addition, 18 of the suspected 29 reactions are included in the drug's monograph.

"This information at this point is strictly observational, they are only suspected to be associated with Accutane. Causal relationships have not been determined," Health Canada spokesman Chris Williams said.

The cases were published in the latest issue of the Canadian Adverse Reaction Newsletter "to stimulate reporting to see if something needs to be done," Williams said.

"That's why we're putting it out."

It's been estimated that as few as one per cent of suspected reactions are ever reported under Canada's voluntary reporting system.

Last year, 10,410 cases of suspected adverse reactions to drugs, blood products and vaccines were reported to Health Canada.

Of those, 7,223, or 69 per cent, were classified as serious.

The number of reported cases of drug reactions has increased steadily over the past seven years, with 1.7 per cent more cases in 2005 than in 2004.

Accutane has been highlighted in the newsletter before: in 1999, Health Canada reported cases of depression and other reactions of a "putative psychiatric nature" in people taking the drug, including aggression and suicide attempts.

Intended as a last-resort drug for the most severe forms of disfiguring acne, Accutane is increasingly being used on milder cases.

The drug is also being prescribed for psoriasis, rosacea and other "off-label" conditions for which it has not been formally approved.

The U.S. government has imposed tighter controls on the use of Accutane.