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Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder

A Descriptive Study

Mosholder, Andrew D. MD, MPH*; Taylor, Lockwood PhD*; Mannheim, Glenn MD*; Ortendahl, Lisa MS; Woodworth, Tiffany S. MPH; Toh, Sengwee ScD

Journal of Clinical Psychopharmacology: October 2018 - Volume 38 - Issue 5 - p 505–508
doi: 10.1097/JCP.0000000000000939
Brief Reports

Purpose/Background Stimulant abuse is associated with cardiomyopathy, but cardiomyopathy rates with therapeutic use of stimulants for attention-deficit/hyperactivity disorder (ADHD) are poorly characterized. Labels for methylphenidate, amphetamine, and atomoxetine caution against use in patients with cardiovascular disease. We sought to assess the incidence of new-onset heart failure or cardiomyopathy among initiators of these medications.

Methods/Procedures Using the Sentinel distributed database, we analyzed new-onset heart failure or cardiomyopathy among initiators of selected ADHD medications (amphetamine products including lisdexamfetamine, methylphenidate, and atomoxetine), by duration of use (0–90, 91–180, 181–270, 271–365, 366–730, and 731–1095 days) and age group (<22, 22–44, 45–64, and ≥65 years).

Findings/Results In our sample of 2,012,948 initiators of ADHD medications, 44.6% were female, and 54.1% were younger than 22 years. Heart failure/cardiomyopathy rates in the age groups younger than 22 and 22 to 44 years old were less than 50 per 10,000 person-years, without clear trends by duration of use. The highest rates occurred soon after treatment initiation in the age group 65 years or older, with 1 case per 10.5 person-years of follow-up, or 950 cases per 10,000 person-years, for days 0–90.

Implications/Conclusions Heart failure/cardiomyopathy rates were not higher over 3 years of ADHD medication use compared with shorter-term treatment. In older age groups, lower rates later in treatment could reflect depletion of patients predisposed to the outcome if they develop it soon after starting treatment.

From the *US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring MD; and

Harvard Pilgrim Health Care Institute, Boston MA.

Received December 4, 2017; accepted after revision July 3, 2018.

Reprints: Andrew D. Mosholder, MD, MPH, Division of Epidemiology 1, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 (e-mail:

This article reflects the views of the authors and should not be construed to represent the US Food and Drug Administration's views or policies.

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.