and Teen Suicide
September 15, 2004
Subject: Drugs called selective serotonin reuptake
inhibitors (SSRIs) have been the mainstay of treatment for depression
for more than a decade. But a number of them are now the focus of intense
controversy, because of evidence linking them to suicidal impulses in
children. What's more, drug firms are under attack for failing to publish
data on these effects.
I've been watching the recent news stories about antidepressants
in children over the last few weeks. The first article of note came
out and suggested that combining Prozac with talking types of counseling
was more effective at treating teenage depression than either drug or
talk therapy alone. That same week a second article on teens and
antidepressants took some of the elation out of the first story.
Use of antidepressants was linked with an increase in teen suicides.
This article prompted me to dig out an old story in the Townsend Newsletter
from a decade ago which said just about the same thing: Prosac and other
SSRIs were associated with sudden violent behavior in some users.
The majority of members of the expert committee that initially reviewed
those concerns were working for or being paid in one way or another by
the manufacturers of the drugs in question.
Today's story is that an FDA advisory committee has told the agency that
they need to put stern warning labels on antidepressants. Here is
a link to a good review of the situation from Science News:
or here is the text of their article:
Published online: 15 September 2004;
Congress considers antidepressant risks for kids
US agency advised to label drugs with stronger suicide warning.
Clinical trial data and passionate testimony from patients,
parents and doctors convinced the committee that the strongest possible
warning is required.
Advisers to the US Food and Drug Administration (FDA) have told the agency
to issue a sweeping new warning about the risks of all antidepressants
The warning would state that such medicines cause some children to try
to commit suicide. This is a step up from warning labels adopted by the
FDA in March, which say that antidepressant drugs are associated with
a risk of suicide in children, but do not necessarily cause it. The warning
would appear on all antidepressants on the market, as well as those approved
in the future. The committee said antidepressants should also be sold
with a guide that tells parents to monitor children on the drugs for suicidal
The advisers came to their conclusions last night after a two-day hearing,
in which they examined data from 24 clinical trials, as well as hearing
passionate testimony from patients, parents and doctors who work with
depressed children. The FDA convened the hearing on 13 September to ask
its advisory committee how to interpret the clinical trials, which examined
the effect in children and teenagers of nine antidepressant medications
on five types of mental illness.
The FDA usually adopts its advisory committee's recommendations, but will
discuss them internally before announcing a decision, says Robert Temple
director of the Office of Drug Safety in the agency's drug evaluation
Those fighting the patients' corner have hailed the committee's recommendations
as a major victory. They say that drug companies are downplaying the risks
of a new family of antidepressants called selective serotonin reuptake
inhibitors, or SSRIs.
Data requested by the FDA last year showed that children who took SSRIs
in controlled clinical trials were more likely to think or act suicidally
than children who did not take the drugs. But drug companies have failed
to publish much of these data, and this has spurred lawmakers, doctors
and journal editors to push for more openness about results.
"The big message from this is the importance of full disclosure," says
Vera Hassner Sharav, president of the non-profit group known as the Alliance
for Human Research Protection.
The advisory committee was also concerned about the information drug companies
distribute about their products. The committee voted 15 to 8 to tell the
FDA to issue a "black box" warning, which is the strongest possible warning
released by the agency. Drug companies must post black-box warnings prominently
in any television or magazine advertisements for their products.
Some psychiatrists on the advisory committee said that black-box warnings
might be the only way to get patients and doctors to pay attention to
negative information about the drugs in the face of a deluge of advertisements.
These ads tout the drugs' benefits even though most of the drugs have
not been shown to help depressed children.
"It is almost a penalty for the intense direct-to-consumer advertising,
which does play a huge role in driving sales for some of these drugs,"
said Bruce Pollock, a psychiatrist at the University of Pittsburgh School
Committee members who voted against the black-box warning were concerned
that it could scare doctors away from using the medications in depressed
children. As a result, these untreated children might kill themselves,
"I fear the black box would impede access to treatment," said Matthew
Rudorfer of the National Institute of Mental Health.
But other committee members pointed out that the clinical trials they
examined show that most of the drugs do not work in children. And they
were concerned by reports from the families who testified on 13 September
that paediatricians had prescribed the drugs for relatively minor ailments,
such as insomnia.
"That somebody would get Zoloft for insomnia is beyond anything I can
understand," said child psychiatrist James McGough of the David Geffen
School of Medicine at the University of California, Los Angeles. He says
the purpose of the black-box warning would be "to inform physicians that
this group of medicines can cause problems".
Most of the drug companies that make antidepressants have not yet responded
to the advisory committee's recommendations. But one, Wyeth Pharmaceuticals
of Madison, New Jersey, says that it supports some aspects of the committee's
"Wyeth will discuss with the agency how to implement the recommendations
of the committee to provide warnings and additional information to physicians,
as well as patients and their parents," the company said in a press statement.
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