ADHD panel rejects tough drug warnings

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An advisory panel to the U.S. Food and Drug Administration recommended yesterday that Ritalin and other drugs to treat attention-deficit hyperactivity disorder not carry so-called "black box" warnings about cardiovascular and psychiatric risks.

With that decision, the Pediatric Advisory Committee broke with another FDA advisory panel that recommended ADHD drugs carry black-box warnings, which are the strongest.

"This meeting was about children, not adults. The efficacy of ADHD drugs in children is quite strong," said Dr. Robert Nelson, chairman of the pediatric committee, in explaining its disagreement with a recommendation of the Drug Safety and Risk Management Advisory Committee.

Rather than a black-box warning, Dr. Nelson and others who met with the press after the committee's daylong session said labels for ADHD therapies should be written so people can understand them. There needs to be improved communication, Dr. Nelson said.

"I wouldn't use the word tougher, but clearer," he said of the changes the panel seeks.

ADHD drugs include Novartis AG's Ritalin, the oldest such treatment; Shire Pharmaceutical Group PLC's Adderall XR; Johnson & Johnson's Concerta and Eli Lilly & Co.'s Strattera.

The panel that convened yesterday considered whether warning labels on ADHD drugs need to be strengthened and, if so, how. They also evaluated whether the drugs posed cardiovascular risks, as the drug safety panel found last month, as well as psychiatric and suicide risks.

In February, the drug safety committee voted 8-7 to require a black-box warning on ADHD drugs because of concerns that the medications may increase the risks of heart attack, stroke and sudden death.

That panel acted after learning that, from 1999 to 2003, 25 persons died suddenly while taking such drugs and that 54 experienced serious cardiovascular disorder (CVD) during that period while on ADHD medicines.

ADHD drugs may pose greater risks of CVD-related illness and death to adults than to children, that committee said, given that CVD primarily affects older people. However, children constitute the largest population taking ADHD medicines, and 19 of the 25 sudden deaths reported occurred among minors.