ADHD panel rejects tough drug warnings

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.

That panel’s pitch for black-box warnings came as a surprise to many, because it was supposed to review plans for more safety studies. The action alarmed some child psychiatrists, who said they were called by parents afterward and told that they planned to discard ADHD medicines their children used.

Most ADHD drugs are stimulants and are regulated like narcotics. At least one commonly used ADHD drug — Adderall XR — carries a warning that misuse of the amphetamine-like drug can lead to sudden death and heart damage. Another drug, Strattera, is not classified as a stimulant and would not require a black-box warning.

Psychiatrists said leaving ADHD untreated could rival any medical risks and noted that problems have been rare.

The FDA is not required to accept the recommendations of advisory panels, but it often does so. In this case, the agency wanted the pediatric panel to weigh in before it decided whether new warnings on ADHD treatments were necessary.

Children remain the largest population taking ADHD drugs to treat problems such as inattention, lack of focus, impulsivity and hyperactivity. But their share is starting to shrink, as it is increasingly recognized that ADHD is a “lifelong disorder,” affecting children and adults alike, said Brian Goodman, spokesman for the organization Children and Adults with Attention-Deficit/Hyperactivity Disorder.

Story Continues →