FDA Told to Delay ADHD Drug Labeling Changes
July 2, 2005 09:09

More safety data is needed, says an advisory panel to the FDA.

release posted on the U.S. Food and Drug Administration's Web site noted that members of the Pediatric Advisory Committee, in a meeting Thursday, did not come across any new concerns about psychiatric side effects with Concerta and other methylphenidates, which include Ritalin and Metadate. Panel members also suggested that the FDA wait until more safety data have been collected on two other types of drugs used to treat ADHD -- methamphetamines such as Adderall and the non-stimulant Strattera.

The FDA should "delay the labeling change until they have a good sense of class effect," Acting Committee Chairman Robert Nelson, of The Children's Hospital of Philadelphia, told FDA officials during the committee meeting, which was convened by the agency.

"Labeling is an oversimplification of the problem," said Dr. Eugenio M. Rothe, director of the child and adolescent psychiatry clinic at Jackson Memorial Hospital and an associate professor of psychiatry at the University of Miami School of Medicine. "It scares people, and it doesn't address the other problems that are affecting the outcome. The problem is much more complex than that, and has to do primarily with the stigma associated with mental health conditions."

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