WASHINGTON — A Food and Drug Administration advisory panel Thursday urged that the strongest possible safety warning be issued for drugs used by millions of children and adults to treat attention deficit hyperactivity disorder, because of emerging concern that they may increase the risks of heart attacks, strokes and sudden death.
The FDA had called the drug safety experts together to help design further research into such risks. But in an unexpected twist, the committee concluded that the evidence of serious risks was so great that a strong new warning -- not just more research -- was needed.
"This is out-of-control use of drugs that have profound cardiovascular consequences," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and member of the panel. "We have got a potential public health crisis. I think patients and families need to be made aware of these concerns."
Although ADHD is commonly associated with children, members of the safety panel emphasized that the drugs could pose a greater danger to adults. The FDA has received reports of about 25 deaths linked to the drugs and of a larger number of cases involving serious health consequences, such as heart attacks.
The panel voted, 8 to 7, to call for a "black box" warning on literature distributed with the drugs -- which include well-known brands such as Ritalin, Adderall and Concerta. As many as 4 million Americans take the medications, and government figures show that about 10% of all 10-year-old boys in the United States get the drugs; about 4% of girls that age use them.
"No one is saying that there aren't children who are desperately dysfunctional and need these drugs," Nissen said. "But it isn't 10% of 10-year-olds."
The safety experts also voted unanimously to recommend that a brochure be provided to patients and families to inform them in greater detail about the risks and benefits of using the drugs. And it urged the FDA to expedite studies to better understand the drugs' effects.
Senior FDA officials said that they would study the panel's recommendations and that they planned to refer the issue to another advisory committee dealing with psychological problems in children. The agency has been criticized in the past as being slow to respond to evidence of health risks associated with medications, including painkillers and antidepressants.
