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Special warning on ADHD drugs urged

Label would say they may increase death, injury risks

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 yesterday.

The 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 was 8 to 7, with one abstention.

One committee member, Dr. Curt Furberg, a professor of public health sciences at 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. ''The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way," Dr. Robert Temple, director of the FDA's Office of Medical Policy, told reporters after the meeting.

Doctors prescribe the ADHD 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.

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, according to Novartis's medical safety director, Dr. Todd Gruber.

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

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.

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

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

Nissen said his suggestion was meant partly to slow what he characterized as the ''out-of-control growth" in use of the drugs.

Dr. Gerald DalPan, a division director in the FDA's Center for Drug Evaluation and Research, said the drugs already carry warnings related to the possible risk they could pose to patients with heart defects.

''We feel this warning is appropriate given our current knowledge of these drugs," DalPan said.

The FDA review that found 25 reports of deaths among the drugs' users between 1999 and 2003 also uncovered 54 cases of serious cardiovascular problems, including heart attack, stroke, hypertension, and palpitations, and arrhythmia. Some of these ADHD drug-treated patients had preexisting heart conditions or hypertension.

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