Hyperactivity

...ba href=/hyperactivity/a/b disorder (ADHD) after hearing about hundreds of cases in which children using the medications experienced frightening hallucinations, often involving bugs and snakes.

But the panel, which focuses on pediatric issues, rejected the idea of calling for so-called "black-box" warnings — the strongest label warnings the FDA can impose — in part because of testimony by psychiatrists and other medical specialists that the drugs fill a critical need for treating mental-health problems in children.

The drugs have been under increased scrutiny in recent weeks because another FDA advisory panel, which focuses on drug-safety issues, urged the FDA to place black-box warnings on some of the drugs because of heart risks.

Most of the medications are stimulants, which raise blood pressure and have been linked to cases of heart attacks and strokes.

Members of the pediatrics committee said such a drastic warning is not needed for children, since they have a very low overall risk of heart problems.

But they said children with heart problems should not take the medications.

ADHD medications include Ritalin, Adderall XR, Concerta and some generics.

It was unclear how the FDA would handle Strattera, which is not a stimulant, but according to some experts appears to have similar effects.

An estimated 4 million to 5 million Americans — mainly children, but also increasingly adults — regularly take ADHD medication.

U.S.

sales of the drugs were recently estimated at...

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

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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 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 co...