New Warnings Urged for ADHD Drugs
FDA Panel Recommends Warnings of Rare Reports of Aggressive Behavior or Psychotic Symptoms
WebMD News Archive
Psychiatric Effects continued...
"Take the child off of it, see what happens. Those are messages we don't
give out enough," says Lauren L. Leslie, MD, a member of the panel and a
researcher at the Child and Adolescent Services Research Center in San
Experts also recommended new labels warning of a possibility of
hallucinations and mania amid dozens of reports that such symptoms can arise
for the first time in children taking ADHD drugs.
Tom Laughren, MD, head of the FDA's division of psychiatric products, says
the committee appeared "unimpressed" by more than 350 reports of suicidal
thoughts or behaviors in treated children over the last five years. Up to 20%
of middle and high school students already report such thoughts, and it was
unclear that drugs other than Strattera led to increased risk, he noted.
But Jacqueline Bessner, of Ishpeming, Mich., told the committee in a tearful
statement that she and her husband were never told to be on the lookout for
suicidal behavior in their daughter, Leanne. The 15-year-old committed suicide
last October 2.5 months after starting treatment with Concerta.
"There was no warning to us that this could have psychiatric behaviors" as
side effects, Bessner tells WebMD.
A separate expert panel last month surprised regulators by urging new "black
box" warnings of cardiovascular risks in the growing number of adults taking
stimulant ADHD drugs.
The drugs are known to increase blood pressure and pulse, and the
recommendation came after preliminary reports suggesting that heart attacks and
strokes were far more common in adults taking the drugs than in individuals who
Experts said that such a warning was not warranted in children, since
reports showed little sign that the drugs increase cardiovascular risk in
otherwise healthy kids.
"In the general run-of-the-mill kid I think they're generally well
tolerated. I don't there's much risk at all if they don't have a heart
condition," said John W.M. Moore, a pediatric cardiologist at the Mattel
Children's Hospital at UCLA and a member of the panel.
Four sudden heart deaths were reported in children taking Adderall XR.
Panelists said the events were most likely due to undiagnosed heart disease in
the children. The risk of stimulant medications in such children should be
added to labels, experts said.