Neuropediatrics 2006; 37 - THP130
DOI: 10.1055/s-2006-945953

SEIZURE RISK IN PATIENTS WITH ADHD TREATED WITH ATOMOXETINE

JF Wernicke 1, KE Chilcott 1, L Jin 1, T Edison 1, S Zhang 1, ME Bangs 1, HA Read 1, DD Ruff 1, AJ Allen 1, D Dunn 2
  • 1Lilly Research Laboratories, Indianapolis, IN, United States
  • 2Indiana University School of Medicine, Indianapolis, IN, United States

Objectives: Atomoxetine was approved in the US for treatment of ADHD in November 2002. As stimulants are often thought to lower the seizure threshold, it is important to consider the relationship between atomoxetine and seizures, especially given the evidence that patients with ADHD may be at increased risk of seizures.

Methods: Data from clinical trials, a claims database study, and postmarketing spontaneous reports were evaluated for evidence of a link between seizures and use of atomoxetine.

Results: Clinical trial data revealed overall seizure reporting rates of 2/1000/year in both the pediatric and adult populations, which were not significantly different than reported in placebo or methylphenidate groups. A claims database study identified 34,727 pediatric ADHD patients whose health claims were observed for 1 year. No statistically significantly increased risk of new-onset seizures among patients receiving atomoxetine was observed (relative risk and 95% CI: 1.1 [0.6–2.1] for current- vs. non-use). During the postmarketing period, the reporting rate of seizure events in the atomoxetine spontaneous safety database was 8.2/100,000, which is well below the range of incidence rates reported in the literature.

Conclusion: There is no evidence that use of atomoxetine is associated with an increased risk of seizures in patients with ADHD.