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FDA Committees Disagree on ADHD Drug Warnings


About three million prescriptions a month are written for drugs to treat Attention Deficit Hyperactivity Disorder, ADHD. The question of the safety of those drugs has just gotten a little more complicated. One advisory committee, for the Food and Drug Administration, is not recommending that the agency put special warnings on the drugs, at least for children. Six weeks ago, a different FDA panel called for the most severe caution, a so-called Black Box Warning.

NPR's Joanne Silberner reports on what the FDA is likely to do.

JOANNE SILBERNER reporting: There are plenty of anecdotes about the risks and benefits of ADHD drugs, like Strattera, and Adderall, and Ritalin, and Concerta. At yesterday's Pediatric Advisory Committee hearings, committee members heard a dozen or more. Winnie Johnson came from Cincinnati to testify. She's adopted ten special needs children; six have taken drugs for ADHD, and she says it made a big difference, especially for Andrew, her eldest.

Ms. WINNIE JOHNSON (Mother of Special Needs Children): There was a dramatic and immediate improvement. He had the same personality but was able to function normally, in and out of school, for the first time.

SILBERNER: Jacqueline Bessmer(ph) testified that her daughter, Lee Ann, had quite a different experience.

Ms. JACQUELINE BESSMER (Mother of Suicide Victim): Lee Ann took her life at approximately two a.m. on October 9th. I found her that morning hanging from her loft bed with a belt tied around her neck.

SILBERNER: But it's enormously difficult to determine if Lee Ann's ADHD drug caused her to kill herself. Surveys consistently show that 15 percent or more of all adolescents think about suicide. Many of them attempt it. The initial safety trials submitted by the drug companies to get market approvals didn't show any major problems with suicidality or anything else.

But those studies were short-term and on only thousands of people. Millions of children and adults take the drugs now. Committee member Judith O'Fallon said more studies on side effects are needed.

Dr. JUDITH O'FALLON (FDA Advisory Committee): We have so little long-term data available to us from these studies, that we really don't have, I don't think, we have a very good idea of how many of these develop further down the line, because the studies are so short. And that's a problem.

SILBERNER: The FDA is looking at data from health insurers, and analyzing reports it's gotten from individual doctors and patients, including reports of sudden deaths in 27 children and adolescents over the course of 13 years, and individual reports about aggressiveness and hallucinations.

In the meantime, committee members agreed that based on the data at hand, the drugs are effective in children, that only Strattera merits a suicide warning, which it already has. They did ask the FDA to promote what's called a Med Guide, a pamphlet that would remind parents that the drugs should not be used in children with known heart conditions. And the drugs by set off events in children with silent heart problems. So if kids develop shortness of breath or heart pains, their doctors should be informed.

They want the guide to note that the drugs may bring out aggression, but more often, they limit aggression, and that the drug may slow children's growth slightly. The FDA's Robert Temple says his agency is likely to follow the advice of its Pediatric Committee.

Dr. ROBERT TEMPLE (Center for Drug Evaluation and Research, FDA): We will turn quite quickly to, I would say, implementing the recommendations we've gotten and revise the labeling accordingly. We would like to get these matters finished of pretty quickly.

SILBERNER: But there's still the question that a different committee raised six weeks ago. The Drug Safety Committee narrowly voted to recommend the Black Box Warning about heart disease in adults, because the drugs can increase heart rate and blood pressure. Temple said the agency is still considering the issue and may need to convene another advisory committee hearing.

Joanne Silberner, NPR News, Washington. Transcript provided by NPR, Copyright NPR.

Joanne Silberner is a health policy correspondent for National Public Radio. She covers medicine, health reform, and changes in the health care marketplace.