Warning label on ADHD drugs sought

Popular drugs used to treat attention deficit and hyperactivity disorder should be labeled with the strongest safety warnings due to rare but potentially deadly side effects, a federal health panel said Thursday.

Stimulants including Ritalin and Adderall have been linked to the deaths of 25 people — 19 of them children — who were being treated for ADHD from 1999 to 2003, an advisory panel of scientists told the Food and Drug Administration.

An additional 54 people suffered heart attacks, strokes and other serious heart problems during that time, according to the panel, which urged the agency to label the drugs with its strongest "black box" warning.

The reports of death or injury amounted, with one exception, to fewer than one case per million prescriptions written.

The black-box warning recommendation comes as ADHD drug prescriptions are booming, particularly among adults, who are more likely to have existing heart ailments.

About 2 million children and 1 million adults are currently on ADHD drugs, which include amphetamines, such as Adderall, and methylphenidates, such as Ritalin, Focalin and Metadate.

Sales of ADHD drugs rose to $3.1 billion in 2004 from $759 million in 2000, according to IMS Health, a pharmaceutical information and consulting firm.

Adult prescriptions alone jumped 90 percent from March 2002 to June 2005, according to the FDA.

"Because adults have a higher risk of heart disease and stroke to begin with, any increase in risk caused by these drugs could affect a large number of people," said Dr. David Graham of the FDA's office of drug safety, which asked the panel to look into potential risks of ADHD drugs.

Psychiatrists said they take the warnings very seriously but also noted stimulants like Ritalin have become crucial in the treatment of ADHD.

"It's been around for about 60 years, and generally speaking it's one of the medications that I consider one of the safest," said Dr. Ramon Solhkhah, chief of child and adolescent psychiatry at St. Luke's-Roosevelt Hospital in Manhattan. "But any time there are reports of severe medical complications or deaths, we as physicians need to look at these issues seriously."

Dr. Robert Temple, director of the FDA's Office of Medical Policy, said the agency will consider the panel's recommendation.

"The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way," Temple said.

A different advisory committee is scheduled to take up the labeling issue next month, he said.

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Contributing: Andrew Bridges, Associated Press