'Black Box' Warning for Antidepressants

FDA has ordered drug companies to add strong warnings about the use of antidepressant drugs, specifically stating that they could increase the risk of suicidal thoughts and behavior in children and adolescents. It has told manufacturers to put a "black box" warning on information sheets that go to patients and doctors. These warnings, which are written in boldface type surrounded by a black border, will warn doctors to closely monitor young patients on these medications and will state that few antidepressants have proven effective against depression in children and adolescents. The information sheets must be given to patients with every prescription. Consequently, drugmakers will have to start delivering antidepressants to pharmacies in individually boxed bottles that include the patient guides rather than in large bulk containers. These actions "reflect what we heard from our advisory committee last month, as well as what many members of the public have told us," Acting FDA Commissioner Lester M. Crawford says.