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Richard Harbus for The New York Times
Dr. Flemming Graae of Westchester Medical Center in Valhalla, N.Y., says he has treated more than 2,000 children with S.S.R.I.'s.

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Drugs (Pharmaceuticals)


Children and Youth


Mental Health and Disorders


Depression (Mental)



British Ignite Debate in U.S. on Drugs and Suicide

By ERICA GOODE

Published: December 16, 2003

Many American psychiatrists were taken by surprise last week when British drug regulators told doctors to stop writing prescriptions for all but one of a newer generation of antidepressant drugs to treat depressed children under 18.

Now the psychiatrists are trying to figure out how to advise the parents of the young patients who come to them for help. Some parents, the doctors say, are calling to ask if the drugs their children are taking are really safe.

"The news has certainly generated anxiety, concern and questions," said Dr. Flemming Graae, the chief of child and adolescent psychiatry at Westchester Medical Center in Valhalla, N.Y.

For parents and psychiatrists alike, the issue is not an easy one to sort out.

The British regulators said that for adults, the benefits of the antidepressants, most belonging to the class called selective serotonin reuptake inhibitors or S.S.R.I.'s, clearly outweigh their risks.

But after reviewing 11 studies of the drugs in treating depressed children and adolescents, the regulators concluded that for most of the medications, the potential for harmful side effects including suicidal thoughts and behavior, as well as hostility was greater than the evidence for their effectiveness. Doctors should not prescribe the medications except in certain circumstances, the regulators said.

The drugs included Paxil, from GlaxoSmithKline; Zoloft, from Pfizer; Effexor, from Wyeth; Celexa and Lexapro, from Forest Laboratories Inc.; and Luvox, from Solvay. Prozac, by Eli Lilly, was exempted from the advisory. (Effexor is a serotonin-norepinephrine inhibitor.)

Few psychiatrists dispute that little is known about how well the drugs work and how they affect the developing brain: the number of large-scale studies of S.S.R.I.'s in children is small, many of the findings are less than impressive, and some drugs have yet to be tested.

And some mental health professionals believe that, given the limited knowledge, antidepressants are being prescribed too widely and too casually by doctors, many of them general practitioners rather than psychiatrists.

But medical experts have sharply divergent opinions on whether governments should intervene in the way that Britain did.

Dr. Richard Harrington, a professor of child and adolescent psychiatry at the University of Manchester in England, said he thought that, on balance, the British regulators did the right thing.

"The broad story seems to be that the drugs don't work and they have some side effects," Dr. Harrington said. "If we're going to practice evidence-based medicine and if the basic evidence is negative, then why prescribe them?"

But some American psychiatrists say the British regulators acted hastily and went too far.

"Everybody scientists, parents and advocates needs an answer to this question," said Dr. John March, the chief of child and adolescent psychiatry at Duke University Medical Center. But the British regulators, he said, "prematurely closed the story."

Dr. March and other experts argue that the cost of leaving depressed children and teenagers untreated is high: depression itself can be a lethal illness. And some psychiatrists say that they have seen "indisputable proof" in their practices that the drugs help seriously ill children.

Most of the experts said they would continue to use S.S.R.I.'s to treat children and teenagers. But they added that doctors and parents should closely monitor children for signs of restlessness, agitation, recklessness, unusual behavior or thoughts of suicide, especially during the first weeks of drug treatment and after any increase in dosage. Some anecdotal evidence suggests that suicidal or aggressive behavior, if it is tied to the drugs, occurs within the first weeks after the drug treatment is started.

Dr. Graae and others say they start children on very low doses of the medications and that in some cases a low dose is all that is needed.


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