
Study results published in the BMJ suggest that up to a year after treatment with isotretinoin, sold by Roche as Accutane, patients with severe acne had an increased risk of suicide.
However, the researchers noted that it is impossible to say whether the rise in suicide risk is "due to the natural course of severe acne, or to negative effects of the treatment."
Accutane, which Roche withdrew from the US market last year due to generic competition, has previously been linked to birth defects if used during pregnancy, as well as mental side effects, although studies have not been conclusive. In the latest trial, researchers assessed data from 5756 people in Sweden who used the drug between 1980 and 1989, linking the records to hospital data and death registers from 1980 to 2001.
The analysis found that during the period, 128 patients were admitted to hospital following a suicide attempt. In addition, the number of suicide attempts rose between one and three years before starting treatment with Accutane, with the risks highest within six months of treatment cessation.
The researchers concluded that although the increased risk of suicide may be "a consequence of exposure to the drug…a more probable interpretation is that the underlying severe acne" is the best explanation.
"The most important proactive measure to be taken would be to closely monitor all patients' psychiatric status, not only during treatment, but also for at least a year after treatment with isotretinoin," they noted.