Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL is not approved for use in pediatric patients.
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.
FDA Warns Paxil Users of Birth Defect Risks
September 28, 2005
GlaxoSmithKline and the FDA are warning that a study has identified a risk of major congenital malformations in infants born to women taking Paxil and Paxil CR during the first trimester of pregnancy.
A long-term epidemiological study suggested an increase in the risk of overall major congenital malformations for Paxil (paroxetine) and Paxil CR compared to other antidepressants."Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients," the FDA said.
Labels for Paxil and other antidepressant drugs already include the possibility that the drugs can cause birth defects.
Last month, Norwegian researchers said Paxil is associated with a higher risk of suicide in adults. The drug, which is currently not approved for use by children, has been the subject of 16 scientific reviews, which were analyzed for the Norwegian study.
