FRIDAY, March 20 (HealthDay News) -- The Forest Laboratories antidepressant Lexapro (escitalopram oxalate) has been approved to treat major depressive disorder (MDD) in people aged 12 to 17, the company said Friday in a news release.
Some 2 million teens in the United States have had a bout of MDD in the past year, the company said.
Approved for adults in 2002, Lexapro is among a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It was evaluated in treating adolescent depression in two placebo-controlled studies, the news release said.
According to the Associated Press, the U.S. Justice Department last month filed a complaint against Forest, alleging that the drug maker had inappropriately promoted Lexapro for use by children. Forest has denied the complaint's allegations, the wire service said.
Lexapro and similar antidepressants include an FDA "black-box" label warning stating they show an increased risk compared to a non-medicinal 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."
The warning advises that anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult "must balance this risk with the clinical need."
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