ROCKVILLE, Md. The Food and Drug Administration has said that results of a study it funded with the National Institute of Mental Health should not prompt parents of children with attention-deficit hyperactivity disorder to halt their children’s stimulant medication regimens, and parents should instead discuss concerns with prescribers.
The study, led by Columbia University researcher Madelyn Gould and published in the American Journal of Psychiatry, indicated a possible link between the medications and sudden cardiac death in children. Still, the FDA said that due to limitations in the study, the data did not change its stance on the risks and benefits of the medications.
“The FDA continues to review drug safety information for stimulant medications used to treat ADHD so that we can give healthcare professionals and families the most up-to-date drug safety information available,” FDA Center for Drug Evaluation and Research director Janet Woodcock said.
The study’s investigators compared the use of stimulant medications in 564 healthy children from across the country who died suddenly, “most likely” due to sudden cardiac disturbance, with the use of stimulant medications in 564 children who died as passengers in auto accidents. Of 564 children who died suddenly, 10 were reported to be taking a stimulant medication at the time, compared with two of the 564 who died in auto accidents.
The agency said limitations in the study included a low frequency of stimulant use reported in the study and control groups; a “significant” time lag between the dates when the deaths occurred and collection of the data; the difference in circumstance of death have explained differences in families’ or caregivers’ abilities to recall information relating to medication use at the time of death; and sudden unexplained death in a child would be more likely to trigger an inquiry into the cause of death than death due to blunt force trauma from an auto accident.