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.
Adderall is made by Shire Pharmaceuticals; Ritalin by Novartis Pharmaceuticals Corp.; Concerta by Johnson &Johnson; Methylin by Mallinckrodt Pharmaceuticals; and Metadate by UCB. Other companies make generic versions of Ritalin.
The black box warning would not apply to Strattera, manufactured by Eli Lilly and Co. That drug is not a stimulant.
Sales of ADHD drugs rose from $759 million in 2000 to $3.1 billion in 2004, according to IMS Health, a pharmaceutical information and consulting firm.
About 2.5 million children between the ages of 4 and 17 take ADHD drugs, according to federal survey data cited by Dr. Andrew Mosholder, a medical officer in the Office of Drug Safety. The survey found 9.3 percent of 12-year-old boys and 3.7 percent of 11-year-old girls take the drugs, Mosholder said.
Adult use of the drugs grew 90 percent between March 2002 and June 2005, he said.
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