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Isotretinoin Is Not Associated with an Increased Risk for Depression or Suicide

During the past year, much attention has been paid to increased risk for depression and suicide as a potential side effect of isotretinoin (Accutane) therapy for acne. To investigate this association, members of the Boston Collaborative Drug Program conducted a large, population-based cohort study using databases from Saskatchewan and the United Kingdom. The manufacturer of isotretinoin sponsored the study.

There were 7195 isotretinoin users in Saskatchewan from 1983 to 1997, about half of whom were male. During the same period, 13,700 patients used antibiotics for acne; about 40 percent were male. Three-quarters of the patients in both groups were between 10 and 29 years of age. Overall, there were more than 1700 cases of depression or psychosis among these patients; 61 percent had anxiety disorders, and about 30 percent had mood disorders. There were no statistical differences between isotretinoin users and antibiotic users in the incidence of these psychiatric diagnoses, suicide, or attempted suicide. Among isotretinoin users, these outcomes were not significantly more prevalent during active treatment or in the 6-month period after treatment than in the 6 months before treatment. The numbers from the U.K. were smaller and limited the conclusions that the authors could draw for some comparisons; however, the researchers did not find among these patients, either, any significant increase in the diagnoses of depression or psychosis during isotretinoin therapy compared with the 6-month period before therapy. The authors conclude that there is no evidence of an increased risk for depression, suicide, or other psychiatric disorders in patients taking isotretinoin.

Comment: The issue of a possible association between isotretinoin use and suicide has caused a lot of concern. The Saskatchewan Database is well suited to this kind of cohort study. Lumping the diagnoses of depression and psychosis may have reduced its specificity. In addition, it is not clear what percentage of suicides were reported and included in the database. Nevertheless, these data and the analysis are reassuring. People do get depressed, and adolescents may be at increased risk, whether they are taking isotretinoin or not. An FDA advisory committee has recently reported on this issue (see http://www.fda.gov/ohrms/dockets/ac/00/backgrd/3639b1.htm). Their recommendation that physicians be educated to recognize depression before prescribing isotretinoin does not indicate a contraindication to use of the acne drug but, rather, suggests an enhancement in patient care.

— NH Shear

Published in Journal Watch Dermatology October 24, 2000

Citation(s):

Jick SS et al. Isotretinoin use and risk of depression, psychotic symptoms, suicide, and attempted suicide. Arch Dermatol 2000 Oct 136 1231 -1236.

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