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Some older stimulant-based drugs used to treat attention deficit hyperactivity disorder (ADHD) in kids may cause rare cases of sudden cardiac death, according to a new study. But the FDA is telling parents not to stop their children's ADHD stimulant medication, in part because the study's limitations may not significantly affect the overall risk-benefit analysis tied to the medications.
The researchers' key finding on the death risks associated with ADHD drugs was based on a comparison of 564 children who died of sudden unexplained causes, and another 564 children who were killed in motor vehicle accidents. Based on autopsy reports, toxicology tests, and parent interviews, researchers found that 10 of the kids who died suddenly had been taking an ADHD stimulant medication, compared with only two of the car accident victims.
The study, Stimulant Treatment of ADHD and Risk of Sudden Death in Children, is published in The American Journal of Psychiatry.
As news of the study broke, the FDA released a Safety Communication saying that, while concerned parents should discuss the safety risks of ADHD drugs with their kids' doctors, they shouldn't stop their children's ADHD medication. That's because the FDA has concerns over the limitations of the data.
Specifically, according to the FDA, limitations of the study include 1) a significant time lag between the children's deaths and the collection of the data, 2) different circumstances of the children's deaths may have led to a difference in families' recall of medication use at the time of death, and 3) a child's sudden unexplained death would be more likely to trigger a post-mortem inquiry than death from a car accident.
Meanwhile, more studies on health risks associated with ADHD drugs are on the way, according to the Wall Street Journal: "The FDA is conducting two more studies to determine the relation of ADHD medicines to death and stroke. One involves children and should be completed in the fall, while the other, in adults, likely won't be released until 2010."