Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration

Abstract

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders in children and although stimulant medications remain first line to treat the disorder, some families prefer nonstimulants. The goal is to analyze the adverse events (AE) associated with nonstimulant medications using post-marketing drug surveillance data. We aim to increase awareness and aide patient education. A retrospective study of adverse drug events with atomoxetine, clonidine, and guanfacine was performed using the Federal Drug Administration Adverse Event Reporting System (FAERS) Database. Results show that the most commonly reported AEs, as defined by FAERS, were ineffectiveness (9.91–14.15%) fatigue (8.93%), and somnolence (8.8–10.16%). Of those taking atomoxetine, suicidal and self-injurious ideation was reported to a similar degree amongst all age groups. Suicidal ideation was listed within the top 20 most reported AEs for all three medications. It is more likely that some patients will experience milder side effects. We suggest providing these data to patients to help overcome the stigma of starting medication, especially if they prefer nonstimulants. Serious AEs are still reported to a small degree, thus monitoring and consistent patient education remains important. We also recommend educating a wider demographic of patients about recognizing potential development of suicidal thoughts.