A new study, published online in the American Journal of Psychiatry, concluded that indicated that “the stimulants may be associated with sudden death.” If your child or teen has been prescribed stimulant medications for ADHD, what should you do?
The Wall Street Journal reports that the Food and Drug Administration (FDA) announced that “children shouldn’t stop taking” medications that “treat attention-deficit/hyperactivity disorder, or AD/HD, despite a study ” published online June 15 in the American Journal of Psychiatry that indicated that “the stimulants may be associated with sudden death.”
The agency, “which partly funded the study,” said, however, that “there isn’t enough evidence to conclude the” medicines “are dangerous, and recommends people continue taking their medications.”
The Washington Post explains, “Children taking stimulant drugs . . . to treat” ADHD “are several times as likely to suffer sudden, unexplained death as children who are not taking such” medications, “according to a study published yesterday that was funded by the” FDA “and the National Institute of Mental Health.”
The study “adds to the evolving puzzle parents and doctors face in deciding whether to treat children with medication.”
In the past, physicians “have speculated about such a connection . . . because stimulants increase heart rate and have other cardiovascular effects.”
Currently, doctors are “advised to evaluate patients for cardiac risks before prescribing” medications for ADHD, such as Adderall [amphetamine/dextroamphetamine] or Ritalin [methylphenidate].
In fact, such medications “have carried warnings since 2006 about an increased risk of sudden death in children or teens known to have serious heart abnormalities,” USA Today points out, but “this is the first study to link the stimulants to sudden death in otherwise healthy young people.”
The AP reports, “Healthy children taking the medications were six to seven times more likely to die suddenly for unexplained reasons than their peers.”
While “the study was partially funded by” the FDA, “agency experts said its methods – which relied on interviews with parents years after a child’s death – may have caused errors.”
Therefore, “the agency urges parents to discuss safety concerns with their doctor, but to keep children on the treatments.”
Meanwhile, the “FDA said it is collecting data for a larger, more in-depth study of the” risks posed by the medications. Government experts estimate that approximately “2.5 million US children” are currently taking medications for ADHD.
In a Safety Communication released on 15 June, the FDA said: “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.”
What they are saying is they are not going to change their advice about the risks versus the benefits of the medication because of the study’s limitations, which they say include:
- The significant time lag between when the deaths occurred and when the data was collected.
- The different circumstances around each death that may have affected how well family members and/or carers may have remembered details of any medication the deceased child had been using.
- Sudden unexplained death in a child would be more likely to initiate a post-mortem inquiry than a death due to blunt force trauma in a motor vehicle accident.
- The low frequency of stimulant medication use by the children in both the study and the control groups.
When scientists highlight a study’s limitations they are in effect saying that another study looking at the same things might reach a different result if it didn’t have those limitations.
“It’s hard to characterize the results as reassuring,” the FDA’s Robert Temple said at a news conference.
Still, Temple said, it’s possible that the study missed stimulant use by the car-accident victims, because the parents of children whose deaths were unexplained might have better recall years later of what drugs they took.
“It’s not a robust finding,” he said, noting that if only one more automobile victim had been found to have taken an ADHD stimulant, the difference between that group and the sudden unexplained death group would no longer have been statistically significant.
But, Temple said, “that doesn’t mean that this is off the table and we’re not concerned about it anymore.”
In fact, the FDA is already co-sponsoring two larger studies that are looking at the link between increased risk of heart attack, stroke and other cardiovascular problems and use of stimulant medication. One study is in children and the other in adults. The results are expected to come out later this year.
If that were the case, he said, it would explain why more children taking stimulant drugs were found in the group that suddenly died than among the children who died in traffic accidents.
With subjects as serious as this, and with parents and carers rightly concerned about what to do about any ADHD medication their children have been prescribed, it is important that research in the service of public health produces results that are robust and reliable, so a small study like this one really needs to be confirmed by more research, preferably with a larger study, especially if there are concerns about its limitations.
Until the larger studies are published, I’d go with the FDA’s advice and urge “parents to discuss safety concerns with their doctor, but to keep children on the treatments.” At least, for now.
You can read more about treatment options for ADHD in my book Why ADHD Doesn’t Mean Disaster.