Experts Urge Stern ADHD Drug Warnings
Surprise Vote Follows Preliminary Study Suggesting Risks
Panel: Don't Wait to Warn continued...
Panelist Steven Nissen, MD, said even if the risks are small, the consequences of severe cardiovascular side effect are so dire that the public should be warned now. Potentially elevated heart risk was most profound for adults, who are already at a higher risk than children for heart attacks and strokes.
"I think we need to tell people because the message isn't out there, given the enormous increase in the use of the drugs particularly among adults," said Nissen, a cardiologist at The Cleveland Clinic. "I want to cause people's hands to tremble a little bit before they write that [prescription]. The only way I know how to do that is to put it in a black box."
The vote met with resistance from several experts, who said they were nervous about placing the FDA's strongest warning on drugs before clear evidence of danger was available. Several said the warning could scare parents away from the drugs, which have shown benefits in improving school performance and social skills in children with ADHD.
"I do think we want to be careful not to stunt the tremendous benefit that can occur in the pediatric population with these drugs," said John W.M. Moore, MD, director of pediatric cardiology at UCLA.
Panelist Arthur A. Levin, director of the Center for Medical Consumers, said a drastic recommendation from the committee was needed, given the potential risks.
"Unfortunately I think we may have to act in this sort of heavy-handed way to get people to pay attention," he said.