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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

or neuroleptic malignant syndrome (NMS)-like reactions. The management of these events should include immediate discontinuation of Lexapro and the concomitant agent and continued monitoring.

Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Lexapro therapy does not affect their ability to engage in such activities.

For pregnant and nursing mothers, Lexapro should be used only if the potential benefit justifies the potential risk to the fetus or child.

Patients should be monitored for adverse reactions when discontinuing treatment with Lexapro. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.

The most common adverse reactions in adults treated with Lexapro (approximately 5% or greater and at least twice the incidence of placebo) are nausea, insomnia, ejaculation disorder, fatigue and somnolence, increased sweating, decreased libido, and anorgasmia. The overall profile of adverse reactions in pediatric patients was generally similar to that seen in adult studies and is described in the package insert. Other adverse reactions that were reported in the pediatric trials at an incidence of at least 2% for Lexapro treated patients and greater than that in the placebo treated patients were back pain, urinary tract infection, vomiting, and nasal congestion.

About Forest Laboratories

Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Fores
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SOURCE Forest Laboratories, Inc.
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