FDA Issues Advisory on Strattera

ADHD drug may increase suicidal thinking in children and adolescents

FRIDAY, Sept. 30 (HealthDay News) -- The U.S. Food and Drug Administration issued a public health advisory this week to alert physicians about reports of suicidal thinking associated with Strattera (atomoxetine), a drug indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD).

Children and adolescents treated with Strattera should be closely monitored for clinical worsening, agitation, irritability, suicidal thinking and behavior changes, particularly during dosage changes and during the first few months of therapy, the FDA says.

The FDA's action is based on the results of 11 clinical trials conducted in children with ADHD and one trial in children with bedwetting. The analysis showed that 0.4% of 1,350 children treated with Strattera reported suicidal thinking compared to no cases in 851 children who received a placebo.

The FDA encourages physicians to report any unexpected adverse events associated with Strattera to Eli Lilly of Indianapolis, Ind., at 1-800-LillyRX or to the FDA MedWatch program at 1-800-FDA-1088.

Strattera has been used by more than 2 million patients since its approval in 2002. The FDA has also directed the manufacturer, Eli Lilly, to develop a medication guide for patients and caregivers.

More Information

Physician's Briefing