A newly published study has suggested that anecdotal reports of a link between Roche’s acne medication Accutane/Roaccutane (isotretinoin) and depression and suicide in young users may be unfounded.
Conversely, the study, which appears in the May issue of Archives of Dermatology, suggests Accutane may in fact reduce depression among this group.
Earlier this month, the US Food and Drug Administration reissued a warning about the drug's active ingredient, which it is monitoring for a proposed link to suicide, as part of a new effort to heighten consumers’ awareness of drug safety issues. Roche first introduced the drug in 1982, and latterly three generic versions have been launched onto the US market.
In the study, a research team headed by Christina Chia of Saint Louis University Health Sciences Centre analysed the moods of teenagers with severe acne who were assigned to either Accutane or more conservative therapy, which included antibiotics and skin creams. They found no evidence of depression in either group, and a slight improvement in mood in the Accutane group that they suggest was probably related to improvement in their acne.
The rate of new cases of depression during the four-month study were similar in both groups, at around 4%, the researchers reported. This ties in with recently updated FDA surveillance data, which found that the number of reported suicides among isotretinoin users was 190 through January 2005. Between 1982 and 2002, there were 165 reported suicides, fewer than the 220 that would be predicted among a typical population of this size.
Despite this, in 2002, Accutane’s label was updated in the USA to include a recommendation that physicians monitor their patients for signs of mental illness. And in April, a study published in the American Journal of Psychiatry showed that isotretinoin exposure led to changes in brain functioning that could predict depression.
Meanwhile, Accutane was one of five drugs highlighted by Dr David Graham as posing a risk to human health at the US inquiry into drug safety, which was spurred on by the recent Vioxx (rofecoxib) withdrawal [[22/11/04a]], although this related primarily to the drug’s link to birth defects [[24/11/04f]].