Hyperactivity

The condition causes trouble with focus as well as ba href=/hyperactivity/a/b and impulsiveness.

Other ADHD drugs include Johnson & Johnson's (Research) Concerta, Novartis's Focalin, GlaxoSmithKline Plc's Dexedrine and Eli Lilly and Co.'s (Research) Strattera.

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The condition causes trouble with focus as well as ba href=/hyperactivity/a/b and impulsiveness.

Symptoms can be so disabling that they interfere with school or work and personal relationships.

Other ADHD drugs include Johnson & Johnson's Concerta, Novartis's Focalin, GlaxoSmithKline's Dexedrine and Eli Lilly's Strattera.

Critics say the drugs are over-prescribed to people who do not need them.

'Well-tolerated'The recent safety concerns have added to the controversy.

FDA reviewers have been working for months to analyze reports of sudden deaths, heart attacks and strokes as well as psychotic behavior such as hallucinations.

FDA staff said they were struck by reports of several children under age 10 who were taking the drugs and mistakenly thought they saw or felt bugs, snakes and worms crawling on them.

The hallucinations and other psychotic episodes most often occurred in patients without any known risks factors for such behavior, FDA staff said.

Panel members said they thought those problems should be highlighted on the ADHD drug labels and described in a patient-friendly guide handed out with prescriptions.

Cardiac problems also should be noted, panel members said, but stressed they are most likely to be seen in children with a history of heart problems or in adults.

"In the general run-of-the-mill kid, I think (ADHD drugs) are well-tolerated.

I don't think there's much risk at all if they don't have a heart condition," said Dr John Moore, a panel membe...

Still, the advisers to the Food and Drug Administration called on doctors and parents to be far more vigilant about the psychiatric side effects, citing rare but serious cases of horrific hallucinations, aggression and suicides by children.

The recommendation by the FDA's Pediatric Advisory Committee came nearly two months after another FDA advisory committee narrowly approved the idea of an black box on ADHD drug cardiovascular risks.

The split decision on "black boxes" - a bold-faced label that often leads to fewer prescriptions and sales - could provide some breathing room to makers of ADHD drugs and may deflect harsher FDA action.

The drugs include Adderall XR, made by Shire P.L.C., and Concerta, made by McNeil Consumer & Specialty Pharmaceuticals.

Provigil, made by Cephalon Inc., is under review for ADHD treatment under the name Sparlon.

The ADHD skin patch Daytrana, made by Noven Pharmaceuticals Inc.

and marketed by Shire, is also under review.

Others drugs affected were Ritalin, made by Novartis AG and several generic firms; Strattera, made by Eli Lilly & Co.; and Focalin XR, also made by Novartis.

An estimated 2.5 million children and 1.5 million adults take ADHD drugs.

The top treatments generated about $3.5 billion in sales last year.

FDA officials still must accept or reject the recommendations.

Officials already indicated they think a stern heart-attack warning is excessive but have not yet made a final decision.

Data on psychiatric...