Reactions 1020 - 25 Sep 2004 US FDA to enhance warnings on antidepressant labelling The US FDA has issued a statement to say that it "generally supports the recommendations" received from the Psychopharmacologic Drugs and Pediatric Advisory Committees regarding increased suicidality in paediatric patients receiving antidepressants. The FDA are now working to strengthen the warnings on antidepressant labelling and to increase the information provided to patients. The Advisory Committees concluded that all antidepressants studied in controlled clinical trials increased the risk of suicidal thoughts and actions in paediatric patients, and that any related warning should be applied to all antidepressants, including those that had not been studied in children. The decision as to whether a ‘black box’ warning should be added was split (15 for yes, 8 for no). The committees thought that access to antidepressants for paediatric patients who may benefit was important; therefore, they did not recommend that the drugs be contraindicated in the US. However, they did recommend that antidepressant labelling include the results of controlled trials of the drugs in children with depression. Food and Drug Administration. FDA Statement on Recommendations of the Psychopharmacologic Drugs and Pediatric Advisory Committees. Media Release : 16 Sep 2004. Available from: URL: http://www.fda.gov 809039389 1 Reactions 25 Sep 2004 No. 1020 0114-9954/10/1020-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

US FDA to enhance warnings on antidepressant labelling

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Reactions 1020 - 25 Sep 2004

US FDA to enhance warnings onantidepressant labelling

The US FDA has issued a statement to say that it"generally supports the recommendations" received fromthe Psychopharmacologic Drugs and Pediatric AdvisoryCommittees regarding increased suicidality in paediatricpatients receiving antidepressants. The FDA are nowworking to strengthen the warnings on antidepressantlabelling and to increase the information provided topatients.

The Advisory Committees concluded that allantidepressants studied in controlled clinical trialsincreased the risk of suicidal thoughts and actions inpaediatric patients, and that any related warning shouldbe applied to all antidepressants, including those thathad not been studied in children. The decision as towhether a ‘black box’ warning should be added was split(15 for yes, 8 for no). The committees thought thataccess to antidepressants for paediatric patients whomay benefit was important; therefore, they did notrecommend that the drugs be contraindicated in the US.However, they did recommend that antidepressantlabelling include the results of controlled trials of thedrugs in children with depression.Food and Drug Administration. FDA Statement on Recommendations of thePsychopharmacologic Drugs and Pediatric Advisory Committees. Media Release :16 Sep 2004. Available from: URL: http://www.fda.gov 809039389