The FDA generally supports the recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committee regarding reports of increased risk of suicidality associated with the use of certain antidepressants in pediatric patients. The FDA is working to adopt new labeling to enhance the warnings associated with antidepressant use.
Among other points, the advisory committees concluded that increased risk of suicidality in pediatric patients applied to all the drugs studied: fluoxetine (Prozac), sertraline (Zoloft), mirtazapine (Remeron), paroxetine (Paxil), venlafaxine (Effexor), citalopram (Celexa), bupropion (Wellbutrin), fluvoxamine (Luvox), and nefazodone (Serzone). The committees also recommended that the results of controlled pediatric trials of depression be included in the labeling for antidepressant drugs. For the full FDA statement on antidepressants in pediatric patients, visit http://www.fda.gov.