New Warnings Urged for ADHD Drugs
FDA Panel Recommends Warnings of Rare Reports of Aggressive Behavior or Psychotic Symptoms
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.
Matthew Cabrey, a spokesman for Adderall manufacturer Shire Pharmaceuticals,
said that the company "agrees with and is supportive" of calls to highlight
adverse events that can occur with use of the drug.
The FDA has not yet issued a decision on last month's call to add black box
heart warnings for adults.
"We have some work to do in adults," said Robert Temple, MD, the FDA's
director of medical policy.