This FDA label preserves the extension of suicidality language to young adults and states that short-term studies did not show increased risk beyond age 24. It reports 14 additional cases per 1,000 under 18, five additional at ages 18–24, one fewer at ages 25–64, and six fewer at age 65 or older; no suicides occurred in the pediatric trials.
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
PDF p. 1 (boxed text); pooled analyses at pp. 3–4
This FDA label preserves the extension of suicidality language to young adults and states that short-term studies did not show increased risk beyond age 24. It reports 14 additional cases per 1,000 under 18, five additional at ages 18–24, one fewer at ages 25–64, and six fewer at age 65 or older; no suicides occurred in the pediatric trials. Pediatric pool: 24 trials, nine drugs, more than 4,400 patients. Adult pool: 295 short-term trials of 11 drugs in more than 77,000 patients.