Washington 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, federal health advisers said Thursday.
A Food and Drug Administration advisory panel voted in favor of the "black box" warning after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote of the Drug Safety and Risk Management advisory committee was 8-7, with one abstention. One committee member, Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be "inappropriate, unethical behavior" not to disclose that there was uncertainty about the safety of the drugs.
The FDA is not required to follow the recommendations of its advisory committees but typically does.
Doctors prescribe the drugs to about 2 million children and 1 million adults a month.
Drugs that would have to carry the warning labels are methylphenidates, which are sold as Ritalin, Concerta, Methylin and Metadate. The labels for Adderall and Adderall XR, both amphetamines, have included the warnings since 2004.
The advisory committee also recommended that the drugs include a medication guide for patients and parents. The vote on that was 15-0, with one abstention.
The FDA had asked the advisers to consider ways of studying the drugs because agency data suggested the drugs were linked to an increased risk of sudden death and serious cardiovascular problems, including heart attacks.