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FDA Wants Tougher ADHD Drug Warnings

Doctors Say They Want More Evidence Of Dangers

POSTED: 4:23 pm EST March 21, 2006
UPDATED: 7:42 pm EST March 21, 2006

The controversial topic of Attention Deficit Hyperactivity Disorder is heating up in Washington this week as a panel of pediatric experts debates the safety of drugs such as Ritalin.

NewsCenter 5's Liz Brunner reported that a Food and Drug Administration panel is recommending the most severe safety warning for the drug, but some physicians want more proof of a risk.

Experts say 2.5 million children take stimulants such as Ritalin and Adderall to control the restlessness and lack of focus caused by ADHD. So when a panel of heart specialists called for a black box warning -- the most severe -- on ADHD drugs last month, parents got nervous.

Newton-Wellesley Hospital pediatrician Dr. Lori Gara-Matthews did her best to calm their fears.

"I always think of this medication as one of the safest medications we can give to anyone, really," she said.

The recommendation came after an FDA report found 25 people, including 19 children, died while taking ADHD medications between 1999 and 2003. But many pediatricians said the panel overstepped its bounds with the warning and that the rate of problems in children taking ADHD medication is no higher than among children in the general population and there is scientific evidence of any danger from the drugs.

"I don't think there are those data to tell us to alter what we're doing and I think what we're really doing with these kind of announcements is really frightening so, so many people who are only trying to do the right thing for their children," said Dr. Leonard Rappaport, of Boston's Children's Hospital.

Some doctors are hoping a group of pediatricians meeting with the FDA this week will help clarify the risks and benefits of ADHD drugs. In the meantime, the nation's largest consumer group is launching Responsible RX, a program aimed at giving parents like Ron Furman the best available information on managing their children's treatment.

"As a parent, you always wonder if this is the right thing. Putting your kid on a drug is a big deal," Furman said.

And it's not just children who rely on these drugs. The number of adults with ADHD is also growing. Experts say about 1 million adults take medication for ADHD.

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