On September 29, 2005, the FDA instructed pharmaceutical manufacturer Eli Lilly and Company to change the labeling for Strattera (atomoxetine) to include a boxed warning . . .
On September 29, 2005, the FDA instructed pharmaceutical manufacturer Eli Lilly and Company to change the labeling for Strattera (atomoxetine) to include a boxed warning about an increased risk for suicidal thinking in children and adolescents who are treated with this product.
Strattera, a selective norepinephrine reuptake inhibitor, was approved by the FDA in 2003 as the first new medication in more than 30 years for use in children and adults with attention deficit hyperactivity disorder (ADHD). As of August 2005, approximately 3 million patients had received prescriptions for Strattera.
The increased risk for suicidal thinking was observed in a combined analysis of data from 12 placebo-controlled trials (duration, 6–18 weeks) involving mo…