FDA: ADHD drug not linked to cardiovascular events

Cooper WO. New Engl J Med. 2011; doi: 10.1056/NEJMoa1110212.

The FDA reported today that medications for the treatment of attention-deficit/hyperactivity disorder are not linked to increased incidence of cardiovascular events in children and young adults.

The report came in the wake of a study in the New England Journal of Medicine.

The studied medications included stimulants (amphetamine products and methylphenidate), atomoxetine, and pemoline (no longer marketed), according to an FDA press release. The adverse cardiovascular events included stroke, MI and sudden cardiac death.

Study findings

The four health systems in the retrospective cohort study were Tennessee Medicaid, Washington State Medicaid, Kaiser Permanente California and OptumInsight Epidemiology. Eligible patients were aged 2 to 24 years. The analysis included 1,200,438 children and young adults, totaling 2,579,104 person-years of follow-up that included 373,667 person-years of current use of ADHD drugs.

There were 81 serious cardiovascular events involved in the final analysis. The overall rate was 3.1 events per 100,000 person-years. There was no association between current ADHD drug use and increased serious cardiovascular risk (adjusted HR=0.75; 95% CI, 0.31-1.85).

Analysis accounting for the individual cardiovascular endpoints yielded a similar result. Current users of ADHD drugs were not at increased risk compared with former users (HR=0.70; 95% CI, 0.29-1.72). There was also no association between ADHD drug use and the risk for the primary outcome measure in alternative analyses which addressed study assumptions.

"This large study showed no evidence that current use of an ADHD drug was associated with an increased risk of serious cardiovascular events, although the upper limit of the 95% confidence interval indicated that a doubling of the risk could not be ruled out," the researchers wrote. "However, the absolute magnitude of such an increased risk would be low."

FDA suggestions

FDA officials encouraged health care professionals to note that stimulants and atomoxetine should generally not be used in patients with serious heart problems, or for whom an increase in blood pressure or heart rate may be of particular concern. Officials also suggested that patients treated with ADHD medications should be periodically monitored for changes in heart rate or blood pressure.

Patients are urged to continue using ADHD medications as prescribed by a health care professional until notified otherwise.

The FDA’s Agency for Healthcare Research and Quality will be conducting three separate but related studies on the potential cardiovascular risks associated with ADHD medications. Further data are forthcoming.

For more information, please visit the FDA website.

Follow the PediatricSuperSite.com on Twitter.