FDA confirms some antidepressants increase suicide risk in some children. In February of 2004, two advisory committees of the U.S. Food and Drug Administration recommended that the FDA warn practitioners about the possible risk of suicide potential associated with antidepressant treatment in children. The information was obtained from clinical trials of medications with children, expert witnesses on suicide research, testimony from families of suicide victims, as well as from those whose children had benefited from antidepressant medication. At a second meeting last year, improvement on antidepressant study designs and monitoring for suicide risk was discussed. Now, federal officials are preparing stronger warnings giving some antidepressants to children after new analyses back a suspected link to suicidal thoughts and behavior. FDA and Columbia University psychiatric specialists have re-evaluated 25 studies involving more than 4,000 young people and eight antidepressants. When all the results were lumped together, young antidepressant users were about 1.8% times more likely to have suicidal thoughts or behaviors than patients given dummy pills. Risk varied widely from drug to drug and among studies of the same drug, but studies of Effexor showed particular risk. At present, changes have been made in the labels for Effexor, Serzone,Wellbutrin, Celexa, Lexapro and Paxil indicating warnings which apply to both adults and children with major depressive disorder. The warnings recommend that patients be observed closely for clinical worsening and the emergence of suicidal ideation and behavior, particularly when they begin treatment and when the dose is changed. The warnings also advise families and caregivers of patients to be alert to those and other symptoms, including agitation and irritability, and to immediately let health care providers know about them. Despite the warnings and possible risks, it should be noted that Major Depression is a serious mental illness which often responds favorably to medication, in both children and adults. |
