Abstract

NEWER GENERATION ANTIDEPRESsants should carry a broader warning of an increased risk of suicidal thoughts and behaviors in not only children and adolescents, but also young adults, recommended a US Food andDrugAdministration(FDA)advisory committee after considering new data fromtheagency.Butinanunprecedented step,thepanelalsorecommendedthatthe warningsincludeinformationonthebenefitsof treatingdepressionandtheriskof suicideassociatedwithuntreateddepression, based on emerging data that warnings about potential adverse effects of medicationsmayleadtoundertreatment and subsequent suicides. ThecommitteemetDecember13and voted 6 to 2 in favor of extending the existingblackboxwarnings,althoughmembers alsoagreed that thewarningshould address thebenefitsof treatmentand the risksassociatedwithdecliningtreatment, said Daniel S. Pine, MD, acting chair of thecommitteeandchiefofchildandadolescent researchat theNational Institute ofMentalHealth.TheFDAhasyet todecidewhether toaccept therecommendations, but typically the agency does follow its committees’ advice.

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