Fed advisers approve 'clearer' warnings on ADHD drugs

WASHINGTON — Federal health advisers said Wednesday that Ritalin and other drugs for attention deficit hyperactivity disorder should not carry strong "black-box" warnings about potential cardiovascular and psychiatric risks.

Rather, the Food and Drug Administration pediatric advisory committee recommended that the drug labels include warning language written so people can understand it. "I wouldn't use the word 'tougher,' said panel chair Dr. Robert Nelson, of the Children's Hospital of Philadelphia. "'Clearer."'

By rejecting the black-box warnings in a consensus decision, the advisory panel broke with another committee that voted just last month to include them on some ADHD drugs.

The FDA was poised Wednesday to follow the more recent recommendations.

"I think we are likely to follow them, yes," said Dr. Robert Temple, director of the FDA's office of medical policy, following the meeting.

Any updated language may not appear on labels until pharmaceutical companies begin using a recently adopted format, something that could take several years. And the FDA may yet require black-box warnings on stimulants to treat ADHD that would alert adults to increased risk of heart attacks, strokes and other similar problems, Temple said.

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.

Psychiatrists and others had urged the committee to move cautiously before recommending strengthened warnings associated with the drugs.

In February, the FDA's Drug Safety and Risk Management advisory committee voted to recommend the agency add the strongest possible warning to some of the drugs regarding their potential cardiovascular risk.

The FDA then asked the pediatric panel to examine that same issue, as well as reports that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug.

Adding black-box warnings to some or all the drugs, which also include Adderall and Strattera, could cause more harm than good, some experts told the panel.

"I suggest confusion, polarizing viewpoints, initial press hysteria. But then what?" asked Julie Zito, a University of Maryland associate professor in pharmacy and psychiatry.