ADHD: stronger words of warning

WASHINGTON — A Food and Drug Administration advisory panel on Wednesday urged beefed-up warnings for drugs used to treat attention deficit-hyperactivity 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 $3.6 billion a year. The medications are considered highly effective in reducing symptoms of ADHD, a condition that can lead to frustration and failure at school and work, and for which there is no known cure.

But some prominent physicians have warned that ADHD drugs are being overprescribed, without regard for patient needs or safety.

FDA medical experts who pored through reports on hallucinations said they were troubled. "It was striking how often young children described various insects, bugs and worms, both visual and tactile — which we haven't seen elsewhere," said Dr. Kate Gelperin, one of the FDA reviewers.

Such hallucinations are extremely rare in young children.