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If it occurs, discontinue escitalopram tablets and initiate supportive treatment ( 4, 5.2) Discontinuation syndrome: When discontinuing escitalopram tablets, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms ( 5.3) Seizures: Use with caution in patients with a history of seizure ( 5.4) Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.6) Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other drugs that affect coagulation may increase risk ( 5.7) Interference with Cognitive and Motor Performance: Use caution when operating machinery ( 5.8) Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.9) Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses ( 5.10) Sexual Dysfunction: Escitalopram tablets may cause symptoms of sexual dysfunction ( 5.11) Adverse Reactions Most commonly observed adverse reactions (incidence ≥ 5% and at least twice the incidence of placebo patients) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence, decreased libido, and anorgasmia ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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The Treat and Reduce Obesity Act, which would allow Medicare to cover FDA-approved anti-obesity medications, has been reintroduced in multiple congressional sessions