Hyperactivity

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The Food and Drug Administration advisory committee recommends against using so-called "black box" warnings about potential cardiovascular and psychiatric risks.

One member of the panel says it favors drug labels that are "clearer" instead of just tougher.

By voting against the "black box" warnings, the pediatric advisory panel broke with another committee that voted last month to include them on the drugs' labels.

The FDA isn't required to follow the advice of its advisory committees, but usually does.

It's estimated that nearly 3.3 million Americans age 19 and younger used an ADHD drug last year.

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...ba href=/hyperactivity/a/b 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 chair 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.

Psychiatrists and others had urged the committee to move cautiously before recommending strengthened warnings of heart attacks, hallucinations and other potential risks 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, in that case to alert doctors, patients and parents of the uncertainty regarding the risk they may pose to the cardiovascular s...

...ba href=/hyperactivity/a/b 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 chair Dr.

Robert Nelson.

“‘Clearer.”' The agency isn't required to follow the advice of its advisory committees, but usually does.

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