Note: This report is greater than 5 years old. Findings may be used for research purposes but should not be considered current.
Recent reviews of U.S. Food and Drug Administration (FDA) Adverse Event Reporting System data have raised concern that attention-deficit hyperactivity disorder (ADHD) medication use might be associated with increased risk of serious cardiovascular disease.
To examine the association between use of ADHD medications and the risk for serious cardiovascular disease, including sudden cardiac death, acute myocardial infarction, and stroke, in children and youth of age 2-24 years.
Retrospective cohort study using automated data from four health plans (Tennessee Medicaid, Kaiser Permanente California, OptumInsight Epidemiology, Washington State Medicaid) in which ADHD medication users were compared to nonusers.
1,200,438 children and youth contributed 2,579,104 person-years of follow-up, including 373,667 person-years of current ADHD medication use.
Baseline and follow-up drug use was assessed from automated records of dispensed prescriptions. The primary outcome was serious cardiovascular disease (sudden cardiac death, acute myocardial infarction, or stroke) identified from computerized databases and confirmed through medical record review.
Cohort members had 81 serious cardiovascular events (3.1/100,000 person-years). Current ADHD medication users had no increased risk for serious cardiovascular events (adjusted hazard ratio 0.75; 95% confidence interval [CI] 0.31 to 1.85). Risk was not increased for any of the individual endpoints, or for current users compared to former users (adjusted hazard ratio 0.70; 95% CI 0.29 to 1.72). Alternative analyses addressing several study assumptions also found no significant association between ADHD medication use and the risk of study endpoints.
Although there was no evidence of increased risk of serious cardiovascular events for current users of ADHD medications, the upper bound of the 95 percent confidence interval indicates that up to a two-fold increased risk cannot be ruled out. However, the absolute magnitude of such an increased risk would be low.