Daily Telegraph

13 January 2003

Shadow over acne sufferers' Holy Grail - Hailed as a wonder drug for sufferers of severe acne, serious questions are now being asked about Roaccutane


THERE is no shortage of acne treatments or advice.

Go to any chemist and you're faced with entire sections devoted to skin care treatments promising miracles.

But for 5 per cent of the population afflicted with the most severe acne, over the counter treatments are not enough. Roaccutane is the drug of last resort, prescribed for patients who have 'not responded to conventional treatments.

Manufacturer Roche Pharmaceuticals says Roaccutane, Accutane in the US, is a "highly effective treatment" for severe acne. But according to former patients and US doctors, the drug is linked to depression and suicide and should be taken off the market.

They say that, at toe very least, warnings accompanying Roaccutane should be intensified. The issue has reached boiling point, with the US having recently completed a two-year investigation which found Accutane had been frequently associated with suicide.

Watchdogs in Europe are reviewing the drug and there are calls in the UK for a commission into the prescribing of Roaccutane. But in Australia the warnings do not reflect these concerns.

US physician and former Roche employee, Dr Donald Marks, believes the Australian warnings must be upgraded. In the US, warnings state the drug may cause depression, psychosis and suicide, as well as aggressive and violent behaviour. In Australia warnings have only recently included the advice that patients experiencing suicidal tendencies should see their doctor. Dr. Marks said Australian warnings should be in line with those in the US. "There's a real need to inform physicians -about the adverse effects of Roaccutane," he said. "It's the government's responsibility to see the drug company provides adequate warnings. Australia should follow the lead of other countries." Dr Marks believes the drug can lead to depression and suicide.

"It's well established that Accutane can cause depression and is associated with suicide," he said. "It's been an accumulation of knowledge over the last five to 10 months. People are becoming more and more aware." Roaccutane, which contains the active ingredient isotretinoin, belongs to a group called retinoids, which are similar to Vitamin A. They work by reducing the oily substance in the skin.

The labelling of the drug is the responsibility of the Therapeutic Goods Administration. "The Adverse Drug Reaction Advisory Committee ADRAC has received a total of 326 reports of suspected adverse drug reactions out of more than 250,000 patients treated with this medicine," the Therapeutic Goods Administration told The Daily Telegraph.

"There were 41 reports of depression and 13 reports of suicide attempts, two of which resulted in fatal outcomes however, there is no clear evidence of a causal link."