Washington – A federal advisory panel on Wednesday rejected recommending that popular drugs used to treat attention deficit hyperactivity disorder should bear the strongest type of warning of the potential cardiovascular and psychiatric risks they pose.
The consensus move by the Food and Drug Administration’s pediatric advisory committee leaves in doubt whether the agency will require the so-called “black-box” labels on the drugs, which include Ritalin.
The panel, in simply recommending easier-to-understand language on the labels, broke with another committee that had recommended last month that the drugs include the more dire warnings.
The pediatric advisory committee, without voting, did recommend adding more information to the labels for the benefit of doctors, patients and parents.
“I wouldn’t use the word ‘tougher,”‘ said panel chairman Dr. Robert Nelson. “‘Clearer.”‘
The agency isn’t required to follow the advice of its advisory committees but usually does.
Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.
