FDA Probes Safety of Attention-Deficit Drugs

The Food and Drug Administration is asking several advisory panels for advice about drugs for attention deficit hyperactivity disorder. Millions of Americans use these drugs for significant problems with inattentiveness, overactivity and impulsive behavior. The first panel will consider how to design studies to determine whether the drugs are safe, and some people say that's moving much too slowly.

Last year, the Canadian government analyzed reports of 20 deaths in four years among people on drugs to treat ADHD. It pulled one of the most popular, Adderall, off the market. Six months later, after considering the data in depth, the Canadians allowed it to be sold again.

But the initial concern raised a lot of questions. Sen. Chuck Grassley (R-IA) is disturbed by the FDA's inaction. He held several hearings about how the agency operates

"It fits into a pattern that the Food and Drug Administration has had in the past, of moving too slowly and not aggressively enough to protect consumers," says Grassley. "And we saw it with Vioxx, we saw it with antidepressant drugs and suicidal behavior in kids."

The FDA won't comment on that charge, but a spokeswoman says that because there's no firm proof right now that the drugs cause problems, the agency is acting appropriately.

The drugs have become increasingly popular. Between 2000 and 2004, there was a threefold increase in the use of Adderall, Strattera, Ritalin, Concerta, and similar drugs.

Psychiatrist James McCracken, of the University of California at Los Angeles, has done clinical research on several of the drugs and has received financial support from manufacturers. He says the FDA's plan is appropriate.

"What the FDA is struggling to understand, or to think about how to research is, with the wider use of these medicines, and also the higher doses that are employed in current practice, should there be an extensive effort to look at this safety question in even more detail, or using more powerful or rigorous study designs," he says.

For example, doing sophisticated heart-function tests that could pick up subtle cardiovascular changes rather than just looking for changes in things such as blood pressure, as was done in the past.

McCracken says that in the meantime, most psychiatrists who treat ADHD are comfortable with the drugs. Some of the drugs have been on the market more than 50 years.

"That has enabled an enormous amount of clinical experience and research experience to accrue, both with respect to the drugs benefits and their safety," he says.

Sen. Grassley's concern is that potentially unsafe drugs will continue to be used while the research is done, and the research could take years.

"While this is going on, we can't waste any time," he says. "We need to let the consumers know that there might be some danger. We need to let parents know."

McCracken's concern is just the opposite. The psychiatrist is worried that adults with ADHD and parents of children with the condition will be scared away from what he considers to be the most effective treatment for the disorder.

The FDA will hold two more hearings in March.

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