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.

$3.5 Billion Market

The drugs include Adderall XR, made by Shire PLC, 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 risks were more solid. "We recommend that these issues be addressed," Kate Gelperin, a drug-safety expert at the Food and Drug Administration, told the committee during a daylong meeting Wednesday.

'Insects, Snakes and Worms'

She said regulators were struck by the number of cases of "hallucinations, both visual and tactile, involving insects, snakes and worms," characterizing the tales as "particularly traumatic and undesirable."

Members of the committee agreed, by consensus, to recommend that the FDA order drug-makers to draft and distribute a detailed "medication guide" outlining the side effects.

The committee also called on the FDA to promote more voluntary reporting to the agency's MedWatch adverse event reporting system, to generate more data about problems.

Currently, only one of the drugs, Strattera, carries a warning label discussing risk of suicide. Adderall XR carries warnings about psychosis and sudden death in people with heart abnormalities. It also carries a warning about heart attacks from "misuse or abuse."

But proper use in otherwise psychologically healthy children is exactly where the FDA researchers said they found problems. One FDA review of real-world data failed to find any tell-tale psychological risk factors that physicians should look out for before prescribing the drugs.

"No risk factors were identified which could account for the majority of reports of psychosis-related events," the report said. "Also of note, in the overwhelming majority of cases, the patient had no prior history of a similar condition."

Suicide Risk

Gelperin said preliminary estimates indicate that as many as 6 percent of children using ADHD medications properly may experience a negative psychiatric side effect.

At least 10 deaths -- six from suicide -- were reported from real-world data on children using Concerta between 2000 and 2005, although not all were directly blamed on the drug. At least four suicide deaths were found in real-world data on children on Adderall or Adderall XR.

The instances of hallucinations or mania in children included tales of a small boy screaming and flailing on a floor trying to catch cockroaches, and a 7-year-old girl running around a room uncontrollably until she fell down, saying she hit a wall that was not there.

One FDA staffer told the committee: "These adverse events seem to be over and beyond 'unmasking' of what this child was going to do anyway. In case upon case of what we read, it really struck all the reviewers."

The FDA officials also said that while the drugs may reduce impulsiveness, they also caused more "aggression, violent behavior and homicidal thoughts."

ADHD Drug Sales Slowing

The FDA review follows scientific and consumer complaints that have slowed ADHD drug sales in the last year. Medco Health Solutions Inc., a for-profit prescription drug-benefit manager, said this week its data indicate the number of children taking ADHD drugs between fell by 5 percent from 2004 to 2005.

A parade of parents, anti-pharmaceutical activists, disease awareness advocates and individual physicians took to the microphone to demand, or bemoan, new restrictions on the drugs.

"It is important to not let the discussion of ADHD medications overshadow the public health crisis of untreated mental health disorders in children," said Cynthia Wainscott, of the industry-supported National Mental Health Association.

But, choking back tears, Jacqueline Bessner of Ishpeming, Mich., recounted how her daughter, Leanne, 15, hanged herself shortly after starting on Concerta. She called on the committee to act decisively, noting it has studied the problem since at least last summer.

"You had the power to save our daughter's life last June but you did nothing," Bessner said.

Before the decision, one doctor, Michael Goodman, chief of neurology at the Jefferson/duPont Children's Health Program, said the problem may not be the drugs but improper or over-prescribing to inappropriate patients.

"If they have an underlying bipolar disorder or a depressive disorder and it looks like ADHD and they get put on stimulant medication, that group already has a higher risk of suicidal activity," Goodman said.

Shire did not comment on the decision.

Strattera-maker Lilly expressed regret for the deaths but insisted its drug was safe.

"The goal in labeling should be to inform patients but should not be to scare patients and families in ways that ends up denying people care," said A.J. Allen, Lilly's medical director for Strattera.

Knight Ridder Newspapers correspondent Dawn Fallik contributed to this report.