Editorial: Experts fear overuse of drug

Saturday, Feb. 11, 2006 | 12:31 p.m.

A Food and Drug Administration advisory panel says the risks of serious cardiovascular complications or death posed by medicines used to treat attention deficit hyperactivity disorder should carry the strictest possible warnings.

The FDA's Drug Safety and Risk Management advisory committee has called for placing so-called "black box" warnings on methylphenidates, which are sold as Ritalin, Concerta, Methylin and Metadate. The committee reviewed dozens of reports of patients dying or suffering such toxic reactions as heart attacks.

The FDA isn't required to abide by the committee's recommendations, but it typically does. However, the committee departed from its usual process by also considering how often these drugs are prescribed.

"There is a sense (that) maybe the diagnosis of ADHD is being applied where it shouldn't be applied," Dr. Peter Goss, the committee's chairman, told the Associated Press. Members cited statistics that show 10 percent of all 10-year-old boys and 9 percent of all 12-year-old boys in America are taking drugs for ADHD. The condition is characterized by inattention and restlessness and has been linked to poor school performance and conduct and drug abuse.

"What is also interesting is this condition is not really recognized in other countries - you wonder what we are treating," Curt Furberg, a committee member and professor at Wake Forest University Medical School, told The Washington Post.

The few existing studies of the drugs' long-term risks provided little information on serious effects. What is more certain, however, is that "black box" labels could curtail marketing directly to consumers.

The FDA should heed the advice of its expert panel and place the strictest, most explicit warning labels available on these drugs until more definitive research is completed. And, given the panelists' concerns, the increasing frequency with which these drugs are prescribed should be studied as well.