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FDA Eyes Rules on Child Anti-Depressants

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WASHINGTON - Federal health advisers considering more stringent warning labels for anti-depressants linked to suicidal thoughts among children were told on Tuesday that a new warning added in March appeared to have little impact on children's use of the drugs.

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Children aged 1 to 17 still account for 7 percent of anti-depressants prescribed, said Michael Evans of the Food and Drug Administration (news - web sites)'s Office of Drug Safety. He quoted IMS Health data for January to June 2004.

While public testimony on Monday and a rival statistical analysis suggested a 10 percent drop in overall anti-depressant prescriptions since the intense FDA (news - web sites) inquiry, "we did not see that," Evans said.

Two-thirds of prescriptions were written by psychiatrists, he said. Ten to 20 percent were written by pediatricians.

Still the FDA advisory panel worried about prescriptions written by people with scant mental health training.

One member of the panel asked the drug agency whether it could require that those prescribing the drugs undergo training to better recognize warning signs.

P. Joan Chesney, chair of the FDA pediatric advisory committee, said her daughter has taken anti-depressants. "I was appalled," Chesney said, upon learning that psychiatrists were signing prescriptions that had been written by social workers, pharmacists and emergency room doctors.

"The people who are prescribing this on the whole are not psychiatrists," she said.

Panel member Dr. Michael Fant agreed: "The off-label use of these medications is fairly promiscuous. And the prescribers extend well beyond those who are trained in the care of the mentally ill," Fant said.

Independent experts and FDA scientists have said there a definite link between anti-depressants and the worsening suicidal fixations of children taking the drugs.

The latest analysis forms the heart of data FDA advisers were considering during the second day of hearings on anti-depressants. Even Prozac — shown in earlier studies to be the most benign anti-depressant for youth — increases the odds of suicidal thoughts and actions.

On average, anti-depressants taken by kids will cause an extra 2 percent to 3 percent to have increased suicidal thoughts, the independent experts, working with Columbia University, found.

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

Two FDA advisory committees, meeting jointly, spent Monday listening to summaries of the current science. And for hours parents described the heartbreak of suicides they blamed on anti-depressants.

Tom Woodward, whose 17-year-old daughter Julie hanged herself while she was on Zoloft, said, "Drug companies have purposely deceived the public about the safety and efficacy of their drugs."

During congressional hearings last week, critics said the FDA and drug companies have provided scant details of pediatric clinical trials for anti-depressants. GlaxoSmithKline, the maker of Paxil, has been hit with a lawsuit accusing it of suppressing studies indicating the drug might increase suicidal tendencies in children.

But drug company representatives testified Monday that the industry's studies had limitations. The studies weren't designed to test whether they made patients suicidal and included no direct drug-to-drug comparisons.

Under legislation passed in 1997, pharmaceutical companies had agreed to do more clinical trials involving children in exchange for six months of exclusive marketing of their drugs. That legislation boosted drug company profits.

Still, Dr. Wayne Goodman, one FDA advisory committee chair, wondered whether that law inadvertently spawned speedy clinical trials designed, from day one, to guarantee a positive finding for the drug.

Two FDA advisory panels are considering whether agency action — including stronger warning labels — is needed on nine anti-depressants linked to heightened suicidal tendencies among children.

Dr. Robert Temple, director of the FDA's office of drug evaluation, said the panel could decide the benefits derived from drugs like Prozac are worth the increased risk. Labels could warn doctors and families to watch closest during the most treacherous time: when children first begin therapy.

Woodward, 47, was one of more than 70 speakers enveloping federal health advisers Monday in an outpouring of emotion, tears and anger. He said his daughter had been taking Zoloft for just seven days when she killed herself.

"We are certain that Zoloft killed our daughter," said Woodward.

Susan Bro, spokeswoman for Zoloft manufacturer Pfizer, would not comment on Woodward's allegations because of pending litigation.

Other witnesses, like Cynthia Wainscott, chairwoman of the National Mental Health Association, urged the FDA not to take away drugs credited with reducing suicides among depressed youths.

She showed panel members a photograph of her granddaughter Jessi, who she said began suffering from depression at age 11. Now 15 and on medication, Jessi has returned to her normal self, her grandmother said.


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