Forest Laboratories, maker of the selective serotonin reuptake inhibitorLexapro (escitalopram oxalate), announced on March 20, 2009 that the FDA had approved the drug for the acute and maintenance treatment of major depression in adolescents 12-17 years of age.
The Associated Press reported last month that the Justice Department had filed a complaint against Forest Laboratories alleging that they had been promoting the off-label use of Lexapro in children. This charge was filed before the FDA approval and the drugmaker has denied any wrongdoing.
The approval of Lexapro was supported by two placebo-controlled trials. In the first study, 12-17 year old patients showed statistically significant greater average improvement from baseline when compared to placebo. In the second study, which involved patients from 7-17 years of age taking Celexa (citalopram), the patients treated with the antidepressant again had statistically significant improvement compared to the placebo group.
The drug company said that the FDA extrapolated from the Celexa study to approve Lexapro based upon the similarity of the two drugs.
Maintenance efficacy was not evaluated in the two studies, but the FDA concluded that that Lexapro is also appropriate for maintenace therapy, based upon adult data.
Lexapro was generally well-tolerated, Forest Laboratories said, with adolescents experiencing adverse reactions similar to those seen in adults, which are described in the current prescribing information.
A press release from the drug maker noted that antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies of major depression and that anyone considering using Lexapro in an adolescent or child should balance this risk with the clinical need to treat depression. Patients should be closely observed during the first few months of therapy as well as anytime they go thorugh a dose change.
depression.about.com
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