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Important Safety Information
Lexapro®
IMPORTANT SAFETY INFORMATION (revised March 26, 2008) – Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Antidepressants increased the risk of suicidality (suicidal thinking and behavior) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of antidepressants in children, adolescents or young adults must balance the risk to clinical need. Patients of all ages started on antidepressant therapy should be closely monitored and observed for clinical worsening, suicidality or unusual changes in behavior, especially at the beginning of therapy or at the time of dose changes. This risk may persist until significant remission occurs. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients.
Lexapro is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), pimozide (see DRUG INTERACTIONS – Pimozide and Celexa), or in patients with hypersensitivity to escitalopram oxalate. As with other SSRIs, caution is indicated in the coadministration of tricyclic antidepressants (TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro) and other psychotropic drugs that interfere with serotonin reuptake may increase the risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin and other anticoagulants may add to the risk. Patients should be cautioned about these risks. SSRIs and SNRIs have been associated with clinically significant hyponatremia. Elderly patients or patients taking diuretics or who are otherwise volume-depleted appear to be at a greater risk. Discontinuation of Lexapro should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. The most common adverse events with Lexapro versus placebo (approximately 5% or greater and approximately 2x placebo) were nausea, insomnia, ejaculation disorder, somnolence, increased sweating, fatigue, decreased libido, and anorgasmia.
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