
The Risks and
Side Effects of Prescription Acne Medications
Azoulay L, Blais L, Koren G, LeLorier J, Bérard A
Isotretinoin (Accutane) and the risk of depression in patients with acne vulgaris: a case-crossover study.
Arch ermatol. 2008 Sep;144(9):1197-9
The purpose of this study was to determine whether treatment with isotretinoin increases the risk of depression in patients with acne vulgaris. It was the first controlled study to establish a statistically significant link between Accutane and depression.
There have been case reports and anecdotal evidence linking Accutane (isotretinoin) with depression since the drug was first approved by the FDA in 1982 to treat severe recalcitrant cystic acne. In 1998 the FDA required that patient packaging information for Accutane include the following warning, “Accutane may cause depression, psychosis and rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. Discontinuation of Accutane therapy may be insufficient; further evaluation may be necessary.”
This Canadian study examined medical and hospital databases in Quebec and identified 30,496 people who had received at least one Accutane or isotretinoin prescription from 1984 through 2003. From that group they further identified 126 people who had been initially diagnosed or hospitalized for depression during the study period and those who filled a prescription for an antidepressant in the thirty days following their diagnosis or hospitalization. Those who had been on antidepressant drugs in the twelve months prior to their diagnosis/hospitalization were excluded.
The researchers compared a risk period of isotretinoin use in the five months prior to the depression diagnosis, with a control period of five months a year before the diagnosis. They found that people taking isotretinoin were more than twice as likely to develop depression.
The researchers concluded that there is a statistically significant association between isotretinoin and depression. They recommend close monitoring of patients receiving isotretinoin and suggest psychiatric assessments of patients prior to and during isotretinoin therapy.
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