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ADHD Drug Atomoxetine Does Not Increase Risk for Suicidal Events

The FDA has warned that atomoxetine might cause greater incidence of suicidal thoughts or behavior for over a decade. New research by the University of Florida College of Pharmacy finds no confirming evidence for the warning.

April 28, 2016

Atomoxetine, a non-stimulant medication for ADHD, known by its brand name Strattera, has carried a black box warning from the FDA since 2005. After reviewing 12 clinical trials involving approximately 2,200 children taking Strattera, and finding one attempted suicide and five suicidal events within 32 days of treatment, the agency warned doctors and parents that Strattera could cause “agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior.” The black box warning was considered a precautionary measure.

Now, a study published April 26th, 2016 in the journal Pediatrics, reports no increased risk of suicide attempts in a group of children ages 5-18 taking atomoxetine when compared to a second group being treated with ADHD stimulant medication.

The researchers at the University of Florida College of Pharmacy used a retrospective two-cohort design with propensity score-adjusted Cox proportional hazard models to evaluate risk in 499,530 children and teens across four states between 2002 and 2006. They wanted to find out if the suicidal ideation found in the clinical trials translated to an increase in suicidal events.

In one group of 279,315 patients taking atomoxetine or stimulants as treatment for ADHD, the researchers found 140 suicide events. In a second group of 220,215 patients taking atomoxetine as a secondary treatment option, 90 suicide events were observed.

In both cohorts of patients, the researchers concluded that treatment for ADHD with atomoxetine was not significantly associated with increased risk of suicidal events.

“The massive safety concern associated with the drug label warning probably affected the prescription choices made by physicians. Our study’s findings indicate that increased suicidal event concerns are not warranted, and some adolescents might benefit from having the black box warning removed from the medication,” says Almut Winterstein, Ph.D., a professor and chair of pharmaceutical outcomes and policy at the College of Pharmacy and co-author of the study.

Journal Reference

1. Stephan Linden, Regina Bussing, Paul Kubilis, Tobias Gerhard, Richard Segal, Jonathan J Shuster, Almut G Winterstein. Risk of Suicidal Events With Atomoxetine Compared to Stimulant Treatment: A Cohort Study. Pediatrics, 2016; 137 (4) DOI: 10.1542/peds.2015-3199.

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