The US Food and Drug Administration (FDA) has issued an alert about
a possible link between antidepressant drug treatment for pediatric patients
with major depressive disorder (MDD) and increased prevalence of suicidal
thinking and suicide attempts.
In an October 27 "Public Health Advisory," the FDA notified physicians
about preliminary data from a review of studies suggesting an excess of reported
suicidal ideation and suicide attempts for pediatric patients receiving certain
antidepressant drugs in clinical trials compared with those assigned to placebo.
The FDA has completed a preliminary review of 20 placebo-controlled studies
involving more than 4100 pediatric patients for eight antidepressant drugs
(citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine,
sertraline, and venlafaxine) studied under the "pediatric exclusivity provision"
of the FDA Modernization Act. The provision provides marketing incentives—6
months of exclusive sales—to manufacturers who conduct studies of drugs
Mitka M. FDA Alert on Antidepressants for Youth. JAMA. 2003;290(19):2534. doi:10.1001/jama.290.19.2534