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Effective Health Care Program

A Multicenter, Observational Cohort Study to Assess the Cardiovascular Risks of Medications Prescribed for Attention Deficit Hyperactivity Disorder

Abstract Archived

Topic Abstract

Attention-Deficit/Hyperactivity Disorder (ADHD) is a syndrome that includes poor concentration, hyperactivity, and impulsive behaviors that are inappropriate for the child's age. ADHD was originally thought to be a condition of childhood, but recent studies suggest that many adults may have symptoms of ADHD. The treatments for ADHD include stimulant medications and behavioral interventions. There now are more than 2.5 million children and 1.5 million adults in the United States. who receive ADHD drugs.

Doubts about the safety of ADHD drug use were raised recently by a U.S. Food and Drug Administration review of its Adverse Event Reporting System (AERS) for cases of sudden death and arrhythmias in conjunction with use of these drugs, which occurred in children and adults. Thus, there is an urgent clinical and public health need to obtain better safety data for these medications to follow up on the initial reports.

The studies conducted under this work assignment will be designed to: 1) assess the relationship between use of medications for ADHD and the risk of serious cardiovascular disease in children and youth, aged 2-24 years; 2) assess the relationship between use of medications for ADHD and the risk of serious cardiovascular disease in adults, aged 25-64 years; and, 3) perform additional analyses that are relevant to decision makers such as clinicians, State Medicaid programs, and parents/patients. We will conduct two retrospective cohort studies of the use of medications for ADHD and the risk of serious cardiovascular disease and arrhythmias in children and adults. An additional manuscript will describe the group’s experience in pulling data from multiple sites and sources for drug safety research and/or describe the validation and adjudication process from medical record reviews vs. electronic data. The cohorts will be identified from 4 sites with large automated databases that include membership, pharmacy, inpatient, outpatient, and death information; data from 3 sites will be used for the study in children and youth, while data from all 4 sites will be used for the study in adults.

Project goals will be met by identifying use of ADHD medications for a cohort of individuals, identifying important cardiovascular outcomes, and assessing the overall risk of serious cardiovascular events in users of these medications compared to persons who do not use the medications. The findings from these studies will inform treatment decisions for those served by Medicaid, SCHIP, and Medicare programs, populations of interest to AHRQ under Section 1013 of the Medicare Modernization Act and other Federal programs.

Journal Publications

Cooper WO, Habel LA, Sox CM, et al. ADHD drugs and serious cardiovascular events in children and young adults. N Engl J Med 2011 Nov 1. [Epub ahead of print]

FDA Drug Safety Communication: Safety review update of medications used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and young adults.