Why is FDA recommending that Paxil not be used for the treatment of pediatric major depressive disorder (MDD)?
FDA is currently reviewing reports of an increased risk of suicidal thinking and suicide attempts related to the use of the drug Paxil in children and adolescents under the age of 18 with MDD. Although FDA has not completed this evaluation, we are recommending that Paxil not be used in the treatment of pediatric MDD. There is no evidence that Paxil is effective in children or adolescents with MDD. Should children using Paxil stop taking it immediately? It is very important that children and adolescents not stop taking Paxil suddenly, as there is a risk of discontinuation effects. Caretakers of children and adolescents currently taking Paxil should consult their doctor to discuss the best course of action. If they are doing well on Paxil, their doctor may advise that they complete their course of treatment. If their doctor advises that Paxil should be stopped, this should be done gradually to minimize the risk of discontinuation effects. If the dose is not reduced gradually, there is a
