FDA approves SSRI for major depressive disorder in teens
A great deal of legal debate has surrounded the SSRI escitalopram oxalate in relationship to its potential use in children and teens, perhaps because of its black box warning regarding possible risk of suicidal thoughts; it may be, however, that this legal debate will subside due to recent events. Lexapro (escitalopram oxalate) has now been approved by the FDA for major depressive disorder in teens ages 12 to 17. The approval comes shortly after the Justice Department filed a complaint against Forest Laboratories, the maker of the drug, saying that the company was promoting off-label use of excitalopram in children; Forest Laboratories denied any involvement in such activities.
Lexapro was approved for treatment of major depressive disorder after two placebo-controlled trials, one which examined the effects of escitalopram in patients ages 12 to 17 and another that examined the effects of citalopram in patients ages 7 to 17. The drugs were found to cause statistically significant greater improvement than placebo alone. Click here to read an article from Health.com that discusses the drug’s approval.