sychiatrists, pediatricians and family
practice doctors said in interviews that they would restrict their
use of antidepressants in the wake of a federal advisory committee's
decision that the medicines should contain severe warnings about the
risks of suicide.
Dr. Alexander Lerman, a child and adolescent psychiatrist in New
York City, said that he would no longer prescribe the medicines to
some children and that for the rest he would sit down with their
parents and discuss in detail the risks of the drugs.
The advisory committee made its recommendation after reviewing
numerous studies of antidepressants. Although no children in any
study of the drugs committed suicide, there were reports of
increased suicidal thoughts and behavior. The risks are greatest in
the first weeks of therapy.
"Some parents are very uncomfortable with their kids being on
medication to begin with," Dr. Lerman said, "and this will be enough
so that some parents will not allow their kids to be on medicines."
Meanwhile, top officials at the Food and Drug Administration have
decided to re-evaluate whether the drugs can cause adults to become
suicidal, too. Dr. Janet Woodcock, the agency's deputy commissioner
of operations, said in an interview that for years the F.D.A. had
largely evaluated the risk of suicide in adults by analyzing the
final outcomes of antidepressant trials. That analysis has shown no
link to suicide or suicidal behavior, she said.
But the agency identified the risk of suicidal thoughts and
behavior in the trials involving teenagers and children by analyzing
in a new way the adverse-event information provided with the trials.
The agency is now gearing up to do the same thing in its adult
trials, a database that includes 234 tests with more than 40,000
"I think there might be more to be learned, based on what we
learned from the pediatric studies," Ms. Woodcock said.
In the meantime, doctors will have to struggle with how to treat
depressed children and teenagers. There are few good options. While
data from 24 studies of nine drugs provided wildly different
estimates of each drug's benefits and risks, the advisory committee
decided that the studies were so small that there was no convincing
evidence that any drug was safer than another. And studies that
included one-on-one talk-therapy failed to show any benefit for that
The advisory committee decided that the suicide warning should
also be placed on the physician prescribing sheets for an older set
of antidepressants called tricyclics. These medicines have largely
fallen out of favor because of the damage they can do to patients'
hearts and the risks that result from overdoses.
The warning was extended to them in part because of the "great
risk in scaring clinicians back to the tricyclics," said Dr. Thomas
Laughren, a top agency official.
Indeed, committee members openly worried throughout their
deliberations that their decision might lead some physicians to stop
treating depression in children and teenagers. In interviews, some
clinicians said the committee's push for a warning had done just
"I can tell you that my writing for antidepressants for kids has
dropped off dramatically," said Dr. Phillip Kennedy, a family
practice physician in Augusta, Ga.
"It used to be that when I saw a kid who was 14, 15 or 16 and who
was really down, I felt very comfortable writing them an S.S.R.I.
prescription," Dr. Kennedy said, referring to a class of
antidepressants. "I don't now."
Whether antidepressant prescriptions for children and teenagers
will really decline is unclear. In March, the F.D.A. issued a
vaguely worded warning about suicide risk, and it had no impact on
prescriptions trends, agency officials said. Nearly 11 million
prescriptions for antidepressants were given to children and
teenagers in 2002, and that total has since been growing steadily.
In the first six months of this year, the number of such
prescriptions grew almost 8 percent.
Indeed, worldwide sales of antidepressants in the 12-month period
ending in March were $19.97 billion, according to IMS Health, a
pharmaceutical information and consulting company, making them among
the biggest selling drugs.
Most physicians have written scores of prescriptions for the
pills with no ill effects. And since doctors are unable to
distinguish between a drug and a placebo effect, many feel the drugs
work quite well. In fact, the drugs have by and large not proven any
more effective in children and teens than placebos, and even in
adults prove better than placebos in only half of all studies.
Still, the warning that the advisory committee is recommending, a
so-called black-box warning on the label that explicitly talks of
the suicide risk, is a serious precautionary measure, and physicians
said in interviews that the promise of such a warning has gotten
their attention. The risk of suicide from the drugs is small. If 100
children and teenagers are given the drugs, two or three will become
suicidal who would not have been suicidal if given placebos.
Dr. Albert Melaragno, a pediatrician in Valencia Calif., said
that five years ago he never prescribed antidepressants. But, Dr.
Melaragno said, the scarcity of psychiatrists and the growing
unwillingness of managed-care plans to pay for mental-health
services has thrust the task of dealing with depressed children and
teenagers onto him.
The new warning will lead him to be more cautious in using the
pills and more likely to refer patients to psychiatrists, he said.
But he feared that many patients who need the medicines will now
"It's raised such a specter with patients that more of the teens
who have the need for treatment will be frightened off of using it
and suffer more because of that," Dr. Melaragno said.