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Sept. 13, 2004, 2:34PM

Researcher warns against antidepressants for kids

Associated Press

WASHINGTON - A Food and Drug Administration epidemiologist who triggered a closer look at suicidal behavior among children taking antidepressants cited independent experts at hearings today who he said support his findings.

In addition to seeing increases in suicidal thoughts among children receiving all the antidepressants he studied, Dr. Andrew Mosholder noted a clustering of serious events involving suicide within the first four days after youths discontinued Paxil treatment.

Mosholder testified before two FDA panels considering whether agency action -- including stronger warning labels -- is needed on antidepressants because they have been linked to suicidal tendencies among children who take them. The joint panel will weigh the benefits of nine drugs given to depressed children against the risk that the remedies may increase suicidal thoughts and suicidal actions among those youths.

Mosholder said analyses of data confirmed "an association of suicidality with antidepressant drug treatment."

He was praised by grieving family members, who wore pins and carried posters and oversized photographs of deceased children whose deaths they blame on antidepressants. Last year, he had requested clarification from GlaxoSmithKline and received data in May 2003 that suggested a link between the company's drug Paxil and increased suicidal acts among children taking the antidepressant.

"He was finally allowed to speak. Last time, he was muzzled," said Vera Hassner Sharav, president of the Alliance for Human Research Protection.

Dr. Robert Temple, director of FDA's office of drug evaluation, told reporters he had no regrets delaying the testimony at a previous hearing because he still fears Mosholder's data are flawed. "Scaring people needlessly, overdoing it, is worrisome also," Temple said.

Last June, the FDA issued a public warning about Paxil. In July, FDA asked all antidepressant manufacturers to resubmit clinical trial data.

Independent experts, working with Columbia University, were asked to review the research. This summer, the Columbia reanalysis came to conclusions that backed Mosholder.

An additional 2 percent to 3 percent of children are likely to incur increased suicidal thoughts from taking any antidepressant, Tarek Hammad, an FDA senior medical reviewer, testified.

Hammad told reporters that looking at all the drug company studies painted a more nearly complete picture. "Then, you can see significant findings," Hammad told reporters.

Relative risks of suicidal behavior or thoughts were highest among youths taking Luvox, Effexor and Paxil and lower among youths taking Celexa, Zoloft and Prozac.

Temple said it was "interesting and persuasive" that studies link all antidepressants to heightened suicidal thoughts and actions among youth. "They all lean the same way, including Prozac now," he said.

Researchers discussed charts that explained individual tragedies: an 18-year-old heeding a voice that called the teen to the roof, but then refusing to jump; self-inflicted cuts that looked like cat scratches; suicidal role-playing with knifes and hanging ropes.

The descriptions brought tears to Lisa Van Syckel, 43, who recognized the self-destructive actions of her daughter while the 15-year-old was taking Paxil. Van Syckel was among 73 family members who reopened painful wounds to prod the FDA to order more strident warning labels on antidepressants they blame for their children's deaths.

Most medicines children take are prescribed off-label, meaning they are not specifically designed or approved for use in children, said Dianne Murphy, director of FDA's office of pediatric therapeutics. Some 100 pharmaceutical products subjected to 200 studies found that about one-quarter of the time, the FDA had changed the dosages for children, found new adverse reactions that occurred only among children or found the drugs didn't work in kids at all.

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