MONDAY, May 16 (HealthDay News) -- Children taking drugs to
control attention deficit hyperactivity disorder appear to be at no
greater risk for heart problems than kids not taking ADHD
medications, a new study finds.
"ADHD medications can increase heart rate and blood pressure, which might be expected to increase the risk of cardiovascular outcomes," said lead researcher Sean Hennessy, an assistant professor of epidemiology at the University of Pennsylvania School of Medicine in Philadelphia.
But this study, comparing ADHD medication users with non-users,
found no difference in the rate of heart problems or deaths between
the groups, Hennessy said.
The findings should reassure parents that drugs such as Ritalin
and Adderall aren't associated with an increased risk of
cardiovascular events, Hennessy said. However, the study may not
put to rest all fears, one expert said.
Dr. Steven Lipshultz, professor and chair of pediatrics at the
University of Miami Miller School of Medicine, doesn't believe this
study has settled the debate because it fails to take into account
children with existing heart problems.
"This in no way says that in children with underlying heart disease the drugs are safe or not safe," he said.
Because of concerns that ADHD medications could increase the
risk of heart problems, the U.S. Food and Drug Administration in
2007 directed manufacturers of ADHD drugs to produce a medication
guide that would alert doctors and parents and patients to this
risk.
Hennessy said there have been some anecdotal reports of death,
heart attack and stroke among children taking ADHD drugs. "However,
given the millions of children using these medications, it is not
surprising that some events would be reported," he said.
In the new study, "there were no validated cases of heart attack
or stroke in children using ADHD medications," he said. "There were
only a handful of cases of sudden cardiac death in children using
ADHD medications, and the risks were not statistically higher than
in the group not taking these drugs."
In a secondary analysis, he and the other researchers did report
"statistically elevated" associations between a principal diagnosis
of sudden death and ventricular arrhythmia on medical claims and
the use of atomoxetine (Strattera), methylphenidate (Ritalin,
others) and "any ADHD medication" among children and teens who were
prevalent users.
However, due to the low rate of subjects who were correctly
diagnosed upon the principal evaluation, the researchers wrote that
these results appeared to be "unreliable in this age group."
About 9.5 percent of U.S. children have parent-reported ADHD,
according to the U.S. Centers for Disease Control and Prevention.
The neurobehavioral condition is characterized by inattention and
hyperactivity that begins in childhood and frequently interferes
with school, family life and social relationships.
The report is published online May 16 in
Pediatrics.
For the study, Hennessy's team used two databases to collect
data on 241,417 children 3 to 17 years old who were taking an
amphetamine such as Adderall, Strattera, or methylphenidate
(Ritalin, Concerta) for ADHD.
In 2007, almost 5 percent of kids 4 to 17 years old were
prescribed one of those drugs, the CDC reported.
The researchers compared incidence of sudden cardiac death,
abnormal heart rhythms and death from any cause among these kids
with rates of these events in 965,668 children not taking ADHD
medications.
After each case was validated with the assistance of outside
experts and some ruled to be wrongly classified, the researchers
found no statistical difference for any of these events, including
stroke, between the two groups of children. In addition, none of
the kids on ADHD drugs was found to have suffered a heart attack,
and no strokes were connected to ADHD drug exposure.
The study was funded by the Irish pharmaceutical giant Shire,
which makes the ADHD drugs Vyvanse, Adderall XR and others.
Commenting on the findings, Lipshultz said, "I feel that this
industry-sponsored study has the potential of being
misinterpreted."
"This study wasn't able to look carefully at where the major concerns are," he added.
The study did not specifically separate those children with
heart disease from others, Lipshultz said, adding that the FDA's
greatest concern was with the use of these medications in patients
with underlying heart disease. In fact, the drugs may be
contraindicated for such children, he said.
These drugs are a great benefit to children with ADHD, Lipshultz
said. "On the other hand, there are still considerable safety
concerns about the use of stimulant therapy in children, especially
children with underlying health conditions," he said.
The authors themselves wrote that because so few cardiovascular
events occurred in the study group, it was not possible to
definitively rule out an association between ADHD drugs and
increased rates of heart problems.
More information
For more information on ADHD, visit the
U.S. National Institute of Mental Health.