ADD & ADHD Health Center

ADHD Drugs: Sudden Death Risk Higher?

June 15, 2009 -- A new study suggests that children and teens who take stimulants like Ritalin for ADHD have an increased risk for sudden cardiac death, but the FDA says the study has major limitations and should not change the way the drugs are used.

There have long been concerns that the stimulants used to treat ADHD may increase the risk for sudden death in children with undiagnosed heart conditions.

The new research finds corroborating evidence for concern, although all agree that the risk of sudden cardiac death is very small.

ADHD Stimulants and Sudden Cardiac Death

Researchers collected data on stimulant use among 564 children and teenagers who died unexpectedly of unknown causes and an equal number who died as passengers in auto accidents. Many of the unexplained deaths were later attributed to previously undiagnosed cardiac arrhythmias.

They concluded that the odds of using stimulant medication were six to seven times greater among the children who died suddenly of unexplained causes than among those who died in car crashes.

Ten children who died of unknown causes (just under 2%) took stimulants, compared to two children (0.4%) who died in auto accidents.

The study does not prove that ADHD drugs cause cardiac deaths. But lead researcher Madelyn S. Gould, PhD, tells WebMD that the results highlight the importance of carefully screening children and teens for heart conditions when the medications are prescribed.

The research was published today online and will appear in The American Journal of Psychiatry.

“These are very rare events, and parents should not be overly concerned,” she says. “This shouldn’t stop anyone from using medications that can help children. But the clinicians who prescribe these drugs must be vigilant about screening and monitoring their patients.”

FDA: Study Doesn’t Prove Link

The FDA and the National Institute of Mental Health funded the study, but FDA officials expressed reservations about the findings in a written statement and news briefing held today.

“Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk-and-benefit profile of stimulant medications used to treat ADHD in children.”

The biggest limitation, FDA officials said, is that information on stimulant use was collected years and in some cases a decade or more after the children died.

They expressed concern that recalling their children's stimulant use many years later might be greater for parents and physicians of children who died suddenly of unexplained causes.

Robert Temple, MD, of the FDA, said an ongoing study of cardiac outcomes among children taking stimulants for ADHD should provide additional information about risk.

Results from this study, also funded by the FDA and the Agency for Healthcare Research and Quality (AHRQ), should be published in a few months, he said.