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The FDA directed manufacturers of all antidepressant drugs to revise its product labeling to include a boxed warning and expanded warning statements that notify health care providers of an increased risk of suicidality, or suicidal thinking and behavior, in children and adolescents. The drug agency is also instructing additional information about the results of pediatric studies be included.
Antidepressant manufacturers have also been informed by the FDA of its determination that manufacturers supply a Patient Medication Guide (MedGuide) to patients receiving the drugs advising them of risks and precautions that can be taken. The MedGuides are being prepared and pharmacists will likely distribute them with each prescription or refill of a medication.
The FDA advises pediatric patients being treated with antidepressants be closely observed for clinical worsening, as well as agitation, irritability, suicidality and unusual changes in behavior, especially during the initial months of drug therapy or if dose changes have been made.
The only antidepressants that have been approved for use in pediatric patients are Prozac for major depressive disorder and Prozac, Zoloft, Luvox and Anafranil for obsessive compulsive disorder. No other antidepressants have been approved for other psychiatric indications in children.
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