The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents

Off-label psychopharmacologic prescribing for children: History supports close clinical monitoring

“…However, the occurrence of suicidal events in community-treated adults and in clinical trials of adolescents which appeared shortly after the launch of this new class of antidepressants [ 39 , 40 ] raised concerns, but these were left unresolved by the FDA. Regulatory events related to the pediatric use of SSRIs and suicidal risks in youth were initiated by Medicines and Healthcare products Regulatory Agency (MHRA) in U.K. in 2003 and rapidly produced a similar scenario in the U.S. in 2004, culminating with a black box warning for all 3 classes of antidepressants, namely SSRIs, tricyclic antidepressants (TCAs) and Other antidepressants [ 41 ].…”

“…∘ SSRI suicidality (ideation, attempts) was noted in an average of 4% of of children and adolescents treated with antidepressants in clinical trials reviewed by regulatory agencies [ 67 ]; other psychiatric adverse effects e.g., behavioral disinhibition, emotionality, activation, irritability, agitation have been found in up to 25% of children treated with SSRIs [ 68 ]; psychiatric adverse effects are more common in depressed youth less than 12 years old than in adolescents [ 41 ].…”