When researchers compared cardiovascular events such as heart attack, stroke, and abnormal heart rhythm among children and teens taking the ADHD drugs to children who did not take them, they found a very low rate of these events and death from all causes in both groups.
The study is the first large analysis to explore the link between ADHD drugs and heart risk in children and adolescents, and the findings should reassure parents and physicians, the study's author tells WebMD.
Early last month, the FDA telegraphed that its own large study of the issue would also prove reassuring, when agency officials recommended no changes in the use of the drugs based on a preliminary review of the data from the study.
“Until the final FDA results are published, our study should provide some additional reassurance,” says University of Pennsylvania School of Medicine associate professor of epidemiology Sean Hennessy, PhD, PharmD. “One of the most important findings was that the risk of death was no higher in kids taking these drugs.”
Close to 2.7 million children and teens in the U.S. take Adderall, Ritalin, Strattera, or other drugs for ADHD.
Several of the drugs have been shown to increase blood pressure and heart rates in children, and reports of sudden cardiac death in young users led to labeling changes for some of them, warning of possible cardiovascular risk in users with heart problems.
In the newly published analysis, Hennessy and colleagues from the University of Pennsylvania and the health group HealthCore Inc. examined Medicaid claims and claims for children who were privately insured from California, Florida, Pennsylvania, New York, and Ohio.
They compared cardiovascular events and other outcomes in about 241,000 children and teens who took ADHD drugs to about a million children and teens who did not take the drugs.
Specific outcomes included sudden cardiac deaths, heart attacks, strokes, and cardiac arrhythmias.
The incidence of all these events was very low in both groups, with none of the ADHD drug users having a heart attack or stroke during the observation period.
No difference between the stimulant users and non-users was seen in the rate of sudden death and users were no more likely than non-users to have cardiac arrhythmias.
The study was funded by Adderall manufacturer Shire.