any 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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