May 16, 2011 -- Children who take Adderall, Ritalin, Strattera, or other drugs for attention deficit hyperactivity disorder (ADHD) are no more likely to die from cardiovascular causes as other children, a new study finds.
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.
Pediatrician: Finding Should Ease Concerns
Pediatrician Andrew Adesman, MD, agrees that the findings and the recent FDA preliminary communication should reassure parents and physicians.
Adesman is chief of developmental and behavioral pediatrics at Steven & Alexandra Cohen Children’s Medical Center of New York.
“The fact that there was no increase in sudden deaths or cardiac arrhythmias in children treated with stimulants should ease concerns, but it is still reasonable and prudent for clinicians to evaluate cardiac risk factors in children with ADHD before prescribing stimulants,” he tells WebMD.
That means asking about heart problems or unexplained seizures or loss of consciousness and family history of sudden, unexplained cardiac death.
In a written statement, Shire Senior Director of Corporate Communications Matt Cabrey noted that the study confirms the safety profile of stimulant ADHD drugs in children and teens.
He added that Shire supports the “careful medical evaluation of cardiovascular risk by physicians for patients diagnosed with ADHD as they seek appropriate treatment.”