Feds Take a Closer Look at the Safety of AD/HD Drugs
By Christina Elston
Ritalin - the drug commonly used to treat adults and children with attention deficit/hyperactivity disorder (AD/HD) - has always been controversial. Debate has ranged from whether the medication is over-prescribed to serious concerns about its side effects.
Now, an advisory panel of the U.S. Food and Drug Administration (FDA) is recommending that Ritalin and other stimulants used to treat AD/HD carry a "black box" warning on their labels. The labeling, the strongest warning the agency issues, would discuss potential cardiac risks that might be associated with the drugs.
The FDA has received reports of 25 cardiac-related deaths among patients using Ritalin and other stimulant medications, as well as amphetamines such as Aderall. Nineteen of the patients who died were children.
But the advisory panel's recommendation has prompted debate in its own right. Several doctors disagree with the decision.
"I am at a loss with the FDA panel recommendation," says Joseph Biederman, M.D., chief of clinical research in pediatric psychopharmacology at Massachusetts General Hospital. "There is overwhelming evidence supporting the safety of stimulants, and the number of deaths does not support a causal link."
"It is clearly not a definitive judgment about the data," echoes James McGough, M.D., co-director of the child and adolescent AD/HD clinic at UCLA Medical Center. He suggests that the call for a warning could speak more to the political climate, and to the personal views of panel members, several of whom expressed belief that these medications are over-prescribed.
McGough says that he believes labeling changes the FDA made to Aderall in 2004 are adequate; the labeling instructs physicians to tell patients with cardiac conditions not to use the drug.
Lenard Adler, M.D., director of the adult AD/HD program at New York University School of Medicine, says he's concerned about the "significant personal and societal risks" associated with leaving AD/HD cases untreated. Adler, whose book on adult AD/HD, Scattered Minds, will be published by Putnam in May, says adults with untreated AD/HD are more likely to change jobs frequently or to be unemployed; they're also more likely to smoke cigarettes, and more likely to get into car accidents. And, McGough points out, a child with untreated AD/HD has a 35 percent chance of developing a substance abuse problem.
Because of continuing debate, the FDA itself has opted to defer any decision on an AD/HD medication labeling change until an additional advisory panel can review the information in March. The agency has requested that several studies be done, in both children and adults, to provide further data on the safety of these medications. "In the context of those studies, we'll get a much better read on the seriousness of the problem," notes Adler.
Christina Elston is the contributing health editor for United Parenting Publications.