Antidepressants Should Not Be Used Off-Label In Children, EMEA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
European Medicines Agency recommends that warnings highlighting the increased risk of suicidal behavior should be included in product information for SSRIs/SNRIs. If the products are used off-label in pediatric populations out of clinical necessity, children should be monitored for suicidal behavior, the agency says.