Thursday, March 23, 2006
A federal advisory panel yesterday rejected recommending that popular drugs used to treat attention deficit hyperactivity disorder bear the strongest type of warning of the 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 "black box" labels on the drugs, which include Ritalin. The panel, in recommending language on the labels that is easier to understand, broke with another committee that 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 the panel's chairman, Robert Nelson. " 'Clearer.' "
The agency is not 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 manager of drug benefit programs.
Psychiatrists and others had urged the committee to move cautiously before recommending strengthened warnings of heart attacks, hallucinations and other risks associated with the drugs.
In February, the FDA's advisory panel on drug safety and risk management recommend the agency add the strongest possible warning to some of the drugs to alert doctors, patients and parents about the uncertainty regarding the cardiovascular risk they may pose.
The FDA then asked the pediatric panel to examine that same issue, as well as reports that psychosis or mania can occur in some juveniles taking normal doses of any ADHD drug.
-- Associated Press