FDA Issues Warning on Strattera

Adolescents who take the nonstimulant medication Strattera face a higher risk of suicidal thoughts.

Children and adolescents who take the nonstimulant medication Strattera (atomoxetine) face an increased risk of suicidal thoughts, according to a September 29, 2005 warning issued by the FDA. The agency warned doctors and parents to monitor these youngsters for "agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior." It also asked Strattera's manufacturer, Eli Lilly & Co, to add a strongly worded "black box" warning to the drug's label.

The agency acted after Lilly reviewed 12 clinical trials involving Strattera. Out of about 2,200 children and adolescents in these trials, one attempted suicide. The review also found that 0.4 percent of children and adolescents taking Strattera had suicidal thoughts. None of the youngsters taking a placebo reported such thoughts. "This action is a precautionary measure only," said child psychiatrist Larry Silver, M.D., chairman of ADDitude's scientific advisory board. "All of the information is not yet in. Be alert, but do not be alarmed."

For more information, go to fda.gov/cder/drug/infopage/atomoxetine/default.htm.