WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when ZOLOFT is started or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Before taking ZOLOFT, tell your doctor and pharmacist about all prescription and over-the-counter medications and supplements you take or plan to take including: those to treat migraines, psychiatric disorders (including other antidepressants or amphetamines) to avoid a potentially life-threatening condition called serotonin syndrome; aspirin, other NSAID pain relievers, or other blood thinners because they may increase the risk of bleeding. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Sertraline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and 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. Sertraline hydrochloride tablets are not approved for the treatment of major depressive disorder in pediatric patients.
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