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Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents
Date:3/20/2009

ality, or unusual changes in behavior, especially during the initial few months of therapy or at times 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 less than 12 years of age.

Lexapro is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), pimozide, or in patients with hypersensitivity to escitalopram or citalopram. As with other SSRIs, caution is indicated in the coadministration of tricyclic antidepressants (TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro) may increase the risk of bleeding events. Patients should be cautioned that concomitant use of aspirin, NSAIDs, warfarin and other anticoagulants may add to the risk.

Lexapro is not approved for use in treating bipolar depression. Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Lexapro should be used cautiously in patients with a history of mania or with a history of seizure disorder. Lexapro should be used with caution in patients with severe renal impairment or with diseases or conditions that produce altered metabolism or hemodynamic responses.

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 concomitant use of Lexapro with other SSRIs, SNRIs, triptans, tryptophan, antipsychotics or other dopamine antagonists is not recommended due to the potential for development of life-threatening serotonin syndrome
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SOURCE Forest Laboratories, Inc.
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