ARTICLE: (The Ottawa Citizen, March 6, 1999)
Accutane, depression lined in 16 more claims


Health Canada has received 16 reports of people becoming depressed, aggressive and even suicidal while taking an acne drug that's at the centre of a massive lawsuit in Britain.

Eight of the cases in Canada were reported in the last year alone.

The drug, Accutane is the most powerful prescription acne medication available.  It's commonly prescribed to treat the most severe cases of the disease.

Accutane's manufacturer is facing a multi-million-dollar legal action from British patients who claim the drug made them depressed, even suicidal -- a charge the company denies.

Since 1983, the year Accutane was approved for use in Canada, the government's Adverse Drug Reaction Monitoring Program has received 16 reports of depression and other reactions of a "putative psychiatric nature" in people who were taking isotretinoin (Accutane).

The reports, which were outlined in a newsletter issued in January, included depression, aggressive reactions, irritability, suicidal tendencies, amnesia, "abnormal thinking" and manic reactions in patients taking Accutane. There was one attempted suicide but no reported deaths.

The cases involved nine women and seven men ranging in age from 15 to 41.

They becan experiencing problems as quickly as one day after starting Accutane to as long as five months after starting treatment. All but one patient was taking the maximum recommended dosage (one to two milligrams of Accutane per kilogram of weight); the remaining patient received incremental doses up to 3 milligrams per kilogram.

According to the newsletter, all but one patient had recovered at the time of the reporting. (No information on the remaining case was available yesterday). In two cases, the patients were also taking antidepressant
drugs at the same time.

The newsletter says that no link has been established between Accutane and depression. However, it warns doctors and other health-care professionals to watch for any signs and symptoms of depression in people taking the drug.

Health Canada spokeswoman Bonnie Fox McIntyre said the government is not considering removing Accutane from the market. "We certainly are aware, and so are clinicians who work with it, of its
risks. But we're also all very well awsare of its benefits for a sector of the population," she said.

Accutane's Canadian manufacturer, Hoffman-LaRoche, said in an interview earlier this week that there is no evidence of a causal link between the drug and depression or suicide. The company says the drug has been used safely for 16 years by more than eight million patients worldwide.

Although the company acknowledges that psychiatric events habe been reported in patients taking the drug, they say the number is "significantly below" what would be expected in the general population, and that
depression isn't uncommon in adolescence especially in teens with severe acne.

Last year, the company strengthened a warning on its product label that advised doctors to watch for signs of depression or suicidal behaviour.

Accutane is considered a breakthrough drug in the treatment of acne, but known side-effects can include dry lips, hair loss, joint pain and liver damage. The drug can also cause severe birth defects if taken for even a
short time during pregnancy.

At least 300 people including relatives of patients who have committed suicide, are planning to sue the drug's British manufacturer for negligence.