Hyperactivity

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The Food and Drug Administration asked its pediatric advisory committee to review reports of potential heart and psychiatric risks and recommend how to relay that information to the public.

The panel was to vote late Wednesday after hours of testimony by drugmakers and the public about Ritalin, Adderall, Strattera and other medications.

The FDA is not required to follow the recommendations of its advisory committees, but usually does.

A different committee voted last month to recommend that the FDA add the strongest possible warning to some of the drugs.

The warning would alert doctors, patients and parents to the uncertainty regarding the risk that the drugs may pose to the cardiovascular system.

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

The reviews included 100 studies of the drugs and reports from doctors, parents and others.

But adding "black-box" warnings to some or all the drugs could cause more harm than good, some experts said.

"I suggest confusion, polarizing viewpoints, initial press hysteria.

But then what?

" asked Julie Zito, associate professor in pharmacy and psychiatry at the University of Maryland.

ADHD drugs were used by nearly 3.3 million patients age 19 and younger last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.

Psychiatrists and others said more...

...ba href=/hyperactivity/a/b disorder should not carry strong "black box" warnings about potential cardiovascular and psychiatric risks.

Rather, the Food and Drug Administration advisory committee recommended that the drug labels be written so people can understand them.

"I wouldn't use the word `tougher,' said the panel's chairman, Dr.

Robert Nelson.

"`Clearer."' 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 agency isn't required to follow the advice of its advisory committees, but usually does.

Nearly 3.3 million Americans 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a drug benefit program manager.

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

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...

...ba href=/hyperactivity/a/b disorder should not carry strong "black box" warnings about potential cardiovascular and psychiatric risks.

Rather, the Food and Drug Administration advisory committee recommended that the drug labels be written so people can understand them.

"I wouldn't use the word `tougher,'" said the panel's chairman, Dr.

Robert Nelson.

"`Clearer."' 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 agency isn't required to follow the advice of its advisory committees, but usually does.

Copyright © 2006, Chicago Tribune Site index News 10 for ...