Study: ADHD Drugs Likely Do Not Boost Heart Risk
New Findings May Ease Fears for Parents and Patients
ADHD Drugs and Heart Risk: Study Details continued...
In all, 81 patients had a serious problem, Cooper tells WebMD. Of the 81 events, seven were in current users of ADHD drugs, 25 events among former users, and 49 among nonusers.
However, overall, there was no significant increase in risk for those on the medicines compared with those who were not, he says.
However, the statistical ''power'' of the study was somewhat limited, Cooper says. For that reason, he says an increased risk of heart and stroke problems among those on the medicine could not be totally ruled out. The risk could be nearly doubled, compared to those not on the drugs, he says.
But in absolute, real-life terms that estimated increased risk would still be very low, he says.
Overall, the chance of heart and stroke problems was about 3.1 per 100,000 people taking the medicine for a year, he says.
So, even if that risk nearly doubled for those on the medicine, he says, that would translate to about 5.7 serious problems for every 100,000 people taking the medicine for a year.
The study was funded by the FDA and the Agency for Healthcare Research and Quality.
Some experts found the findings more reassuring than others. "This paper does not settle the question about the safety of ADHD drugs," says Steven Nissen, MD, chair of cardiovascular medicine at Cleveland Clinic.
The researchers only looked at the most serious problems, Nissen says. He worries about the long-term effects of the drugs. He suggests parents ask for the lowest dose possible if their children need the medications.
"It doesn't settle the question, but it certainly goes a long way to allaying parents' fears about whether or not medications are safe," says Tim MacGeorge, MSW, director of the National Resource Center on ADHD, a clearinghouse of CHADD (Children and Adults with Hyperactivity Attention Deficit Disorder). "The study does help to quantify the risk."
The new study findings provide additional reassurance that the ADHD medicines ''do not put otherwise healthy patients at increased risk for serious cardiovascular events," says Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park.
He reviewed the findings but was not involved in the study. He reports participating in a one-day advisory board meeting for Noven Pharmaceuticals, which makes an ADHD drug.
He says the sample size of more than 1 million lends credibility to the study.
"Although the authors acknowledge that they cannot rule out a modest increase in risk, the data are overall quite reassuring, especially considering that they did not exclude children with congenital heart disease -- a group presumed to be at increased cardiovascular risk [already] -- from the analysis," Adesman says.