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Psychiatric adverse events in patients taking isotretinoin as reported in a Food and Drug Administration Database from 1997 to 2017

JAMA Dermatology Jul 08, 2019

Singer S, et al. - In this retrospective study, researchers assessed reports of isotretinoin [highly effective medication for severe acne]-related psychiatric adverse events presented to the US Food and Drug Administration between January 1, 1997, and December 31, 2017. Between 1997 and 2017, the US Food and Drug Administration recorded 17,829 psychiatric adverse events with isotretinoin use, with most frequently reported depressive disorders, emotional lability, and anxiety disorders. Although the use of isotretinoin has frequently recorded depressive disorders and suicidality, these reports must be regarded in the context of high levels of depression and suicide among patients with acne at large. The results of this study indicate that patients taking isotretinoin may have a reduced rate of completed suicide than that of the general population in the United States. There have also been reports of many psychiatric adverse events unrelated to depression and suicidality, but it is uncertain whether they have been the consequence of isotretinoin treatment. While no causal connection has been identified between isotretinoin and psychiatric risk, patients taking the drug appear susceptible to psychiatric issues. Monthly mandated iPLEDGE visits can provide a chance for patients to screen for psychiatric circumstances and enhance results.
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