FDA, on Monday, was quick to explain the results of a study that found a minute correlation between the sudden death of children and the death of children in car accidents, and the use medication for the treatment of attention-deficit hyperactivity disorder.
The agency co-funded a study that looked at the use of stimulant medication in children that died of sudden cardiac deaths. Conducted by Columbia University, the study used a case-control method that studied medication usage patterns in people who have the outcome of interest—sudden unexplained death—and people who don’t.
They assessed usage of stimulant medication in 564 children who died of SUD, and compared it with patterns of stimulant medication usage in 564 children that died in car accidents. Of the children that died of SUD, 10 had used stimulant medication, compared to only two in the control group.
While FDA doesn’t find the results of the study reassuring, neither does the agency think they are threatening. Rather, FDA advises that doctors continue to distribute stimulant medication for ADHD according to the current labeling.
“This has been an area of interest for us for a considerable period of time,” said Robert Temple, FDA's director of medical policy. “The drugs that we are talking about are relatives of amphetamines, which are relatives of drugs that are known to stimulate the heart.”
FDA had already concluded that these drugs pose to risk to children with underlying heart disease, which led to new labeling on ADHD drugs. The question has been whether or not there is a risk for people that don’t have an underlying heart disease.
“Everything depends on whether the people who died were or were not taking an amphetamine, and since the deaths took place a long time ago—and in most cases blood levels weren’t relevant—all this depended on the memory of people involved with the victim,” Temple said in a conference call.
The study’s limitations include:
•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
•There was a low frequency of stimulant use reported in both the study group and the control group.
Two additional studies are underway to further delve into the possibility that amphetamine use could raise the risk of SUD.