FDA Issues Safety Communication about an Ongoing Review of Stimulant Medications Used in Children with ADHD
"There may be an association between the use of stimulant medications for attention-deficit hyperactivity disorder, known as ADHD, and sudden cardiac death in healthy children, according to a study published in the American Journal of Psychiatry. But the U.S. Food and Drug Administration says that, because of the study’s limitations, parents should not stop a child’s stimulant medication based on the study. The FDA recommends that parents should discuss concerns about the use of these medications with the prescribing health care professional.

The FDA can not conclude that the data in the study affect the overall risk-benefit profile of stimulant medications used to treat ADHD in children.

The study’s limitations include:

--a significant time lag between the dates when the deaths occurred and collection of the data;
--the difference in circumstance of death may have accounted for a difference in family or caregiver recall of information relating to medication use at the time of death;
--sudden unexplained death in a child would be more likely to trigger a post-mortem inquiry into the cause of death than death due to blunt force trauma as a result of a motor vehicle collision; and
--there was a low frequency of stimulant use reported in both the study group and the control group..."