Apremilast and suicidality: a retrospective analysis of three large databases: the FAERS, EudraVigilance, and a large single-center U.S. patient population

Abstract

Apremilast is a small molecule phosphodiesterase-4 inhibitor approved by the United States Food and Drug Administration (FDA) in 2014 for the treatment of adult patients with moderate-to-severe plaque psoriasis and for psoriatic arthritis.¹ Worsening depression, suicide attempts, suicidal ideation, and suicidal behavior have previously been reported in clinical trials and post-marketing surveillance data, and details are included in the Full Prescribing Information.¹ Moreover, a post-marketing statement recently issued now indicates that completed suicide has also been reported.²

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