Panel urges ADHD drug warning

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ASSOCIATED PRESS

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 yesterday.

The Food and Drug Administration (FDA) advisory panel voted in favor of the "black box" warning after hearing about the deaths of 25 persons, including 19 children, who had taken the drugs. The vote 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 it 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 Drug Safety and Risk Management advisory committee also recommended that the drugs include a medication guide for patients and parents. That vote 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. Various other companies make generic versions of Ritalin.

Novartis said Ritalin, approved by the FDA in 1955, is safe and effective. A company review of more than 50 years of records shows no apparent increase in cardiovascular problems associated with the drug's use, said Novartis' medical safety director, Dr. Todd Gruber.

He told the committee that the drug's label advises caution in patients with certain pre-existing heart conditions.

The FDA had asked the advisers to consider ways of studying the drugs because agency data suggested that the drugs were linked to an increased risk of sudden death and serious cardiovascular problems, including heart attacks.

The committee, however, quickly began debating whether it should consider new warnings for the drugs rather than the need for more studies.

Dr. Steve Nissen, medical director of the Cardiovascular Coordinating Center at the Cleveland Clinic, told fellow committee members that they should recommended the black box warning.