Little evidence of acne drug disturbing patients

A controversial acne drug, isotretinoin - originally sold under the brand names Accutane and Roaccutane - appears to cause few adverse reactions when used in lower dose regimens, according to a review of more than 1700 New Zealand patients.

The drug had high rate of success for improving acne but developed a controversial reputation for side effects, including depression - claimed to have led to suicidal thinking in extreme cases - excess drying of the skin and severe birth defects if taken during pregnancy.

It was first developed to be used as a chemotherapy medication for the treatment of brain cancer, and pancreatic cancer but later adopted in 1982 to treat severe inflammatory acne when other treatments failed.

Swiss drugmaker Roche said it faced high costs from personal injury lawsuits, and last year announced that it planned to stop selling it branded forms of the acne drug - at about the same time drug agency Pharmac allowed authorised general practitioners and nurse practitioners in New Zealand to prescribe the medicine once they had specific training.

Rival manufacturers, Teva Pharmaceutical Industries Ltd, Mylan Inc, and Ranbaxy Laboratories Ltd, have continued selling generic forms of isotretinoin.

Now, a review conducted by Professor Marius Rademaker of the dermatology department at Waikato Hospital in Hamilton, has found no evidence of suicide or suicidality among New Zealand patients.

The six-year study showed that when used in doses of around 10-20mg per day for patients with acne vulgaris, isotretinoin did not appear to be associated with any serious adverse reactions, according to a report on the study published online at the weekend in the Australasian Journal of Dermatology.

The main side effects noted were inflammation and cracking of the skin of the lips, which in most cases was mild and easily managed by patients. The review showed these effects were dose-dependent, with a low incidence of reactions when the drug was used in daily doses equivalent to less than 0.25mg/kg of bodyweight.

Prof Rademaker said that evidence was now accumulating that 10-20mg per day was quite adequate for most individuals with acne vulgaris.

Mood changes and tiredness were seen in 7 per cent and 12 per cent of patients using isotretinoin, but levels were halved when doses below 0.5mg/kg bodyweight a day were used.

"Most cases of mood change were preceded by symptoms of tiredness, although some patients had difficulty in distinguishing between the two; the self-reported severity was mild in most cases but mood change did contribute to stopping the medication in 13 patients," Prof Rademaker said.

- NZPA