TRIP

Experts want suicide risk warning on ADHD drug

Reuters Health News, 2012

Mon, Jan 30 2012 Fri, Jan 27 2012 Fri, Jan 27 2012 Fri, Jan 27 2012 Fri, Jan 27 2012
GAITHERSBURG, Maryland (Reuters) - Children who take a common drug for attention deficit disorder should be warned about the risk of suicidal thoughts, U.S.
Several members of an advisory committee to the Food and Drug Administration asked the agency to change the label for Focalin, an attention deficit medicine made by Swiss drugmaker Novartis AG, to reflect this risk.
The FDA said it received eight reports of suicidal thoughts for children or adolescents who took the drug over the past six years, and four of the cases appeared to be linked to the medicine.
But the FDA said the risk of suicidal thoughts did not appear in clinical trials for Focalin, and the later reports were a tiny number compared to how many children used the drug.
"I'm somewhat puzzled by the focus of suicidal ideation," said Tom Laughren, head of the FDA's psychiatric products division, in response to the panel's recommendation.
And what you're seeing here are a handful of reports that are difficult to interpret with regard to causality," he said.
The number of children diagnosed with attention deficit hyperactivity disorder (ADHD) has skyrocketed in recent years, with the condition now affecting 3 to 5 percent of kids globally.
Children with ADHD are excessively restless, impulsive and easily distracted, and often have trouble at home and in school.
There is no cure, but the symptoms can be kept in check by a combination of behavioral therapy and medication.
Some patient advocates say doctors and parents may be too quick to diagnose kids with the condition, and the drugs may cause side effects that can damage children's health.