New Warnings on ADHD Drugs

An article from the Associated Press on February 9, 2006 reports that experts from the US Food and Drug Administration (FDA) advisory panel have recommended that Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury. The story, reported by Andrew Bridges, noted that the FDA advisory panel voted in favor of a "black box" warning. This came after the panel heard about the deaths of 25 people, including 19 children, who had taken the drugs.

Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, and one of the FDA panelists said it would be "inappropriate, unethical behavior" not to disclose that there was uncertainty about the safety of the drugs. The AP article did note that the FDA is not required to follow the recommendations of the panel.

Dr. Robert Temple, director of the FDA's Office of Medical Policy, told reporters, "The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way." The article also reported that doctors prescribe these drugs to about 2 million children and 1 million adults a month.

Dr. David Graham, a medical officer at the FDA's Center for Drug Evaluation and Research summed up his concerns by saying, "There's smoke. Does that mean there's fire? We wouldn't be going through this exercise if we didn't think there was a real possibility of increased risk."

These drugs are big business. The article noted that in the year 2000, sales of these drugs was at $759 million. That number rose to $3.1 billion by 2004. Additionally it was noted that about 2.5 million children between age 4 and 17 take ADHD drugs including 9.3 percent of 12-year-old boys and 3.7 percent of 11-year-old girls.