The US Food and Drug Administration (FDA) generally supports the recommendations that were recently made to the agency by the Psychopharmacologic Drugs and Paediatric Advisory Committees regarding reports of an increased risk of suicidality (suicidal thoughts and actions) associated with the use of certain antidepressants in paediatric patients.

FDA has begun working expeditiously to adopt new labelling to enhance the warnings associated with the use of antidepressants and to bolster the information provided to patients when these drugs are dispensed.

The committee supported FDA's approach to classifying and analyzing the suicidal events and behaviours observed in controlled clinical trials and expressed their view that the new analyses increased their confidence in the results- concluded that the finding of an increased risk of suicidality in paediatric patients applied to all the drugs studied (Prozac, Zoloft, Remeron, Paxil, Effexor, Celexa Wellbutrin, Luvox and Serzone) in controlled clinical trials.

The committee also recommended that any warning related to an increased risk of suicidality in paediatric patients should be applied to all antidepressant drugs, including those that have not been studied in controlled clinical trials in paediatric patients. It recommended that the results of controlled paediatric trials of depression be included in the labelling for antidepressant drugs, FDA said in a release.