Overview of Psychiatric Adverse Event Association with Isotretinoin An understanding of causality in drug-associated adverse reactions is important for maximizing safe and effective use. Causal linkage between isotretinoin treatment and psychiatric events

An understanding of causality in drug-associated adverse reactions is important for maximizing safe and effective use. Causal linkage between isotretinoin treatment and psychiatric events cannot be established from the observations in post-marketing reports due to under-reporting, the high background incidence of psychiatric illness in the population, and the incomplete nature of spontaneous reports. However, the observations available in the spontaneous reports and in the published literature provide signals for consideration in determining what measures should be taken in response to the reported events.