WASHINGTON - Families and doctors should
be cautioned that children taking antidepressant drugs may be at an
increased risk for suicidal behavior and thinking, and the
government should require a prominent ``black box'' warning label on
the medications, an expert panel concluded Tuesday.
If adopted, the recommendation by the panel advising the Food and
Drug Administration would mark a significant shift in the
government's regulatory stance toward the widely used drugs -- which
include Prozac, Paxil, Zoloft and Celexa -- for treating children
with depression, anxiety, obsessive-compulsive disorder or other
Such a warning would raise the stakes for physicians deciding
whether to prescribe the drugs and would encourage parents and
doctors to pay much closer attention to research that has raised
questions about whether the drugs are safe and effective for
children, experts said.
Expressing the dilemma faced by the expert panel, chairman Wayne
Goodman, a psychiatrist at the University of Florida in Gainesville,
said he wanted to discourage casual use of the drugs while
preserving doctors' ability to carefully assess children and
prescribe the medications when needed.
``We can't ignore there is data out there that points to the
effectiveness and protective action of these drugs against
suicide,'' Goodman said. ``Given what we know, I am not ready to ban
Several psychiatrists told the panel during two days of hearings
that the failure of many studies to show that the drugs worked does
not mean they are ineffective. Many families testified that the
medications helped their children.
But panel member Thomas Newman, a professor of epidemiology at
the University of California-San Francisco, said: ``We have very
strong evidence of harm and not very strong evidence of efficacy. It
would not be bad if use of these drugs were diminished.''
The panel's recommendation comes as use of the medications has
soared despite growing evidence of their risks. Many panel members
blamed pharmaceutical industry marketing for prompting clinicians to
prescribe the drugs.
Short of an outright ban, a ``black box'' warning is the most
serious caution the FDA can require. Several panel members said they
hoped it would discourage drug companies from advertising
antidepressants to patients, especially on TV. The warning would not
preclude such marketing, experts said, but the requirement that the
caution be included in any ads could make them unappealing or
The rulings came at the end of two days of high drama in
Bethesda, Md., where experts were told about a new FDA analysis of
24 antidepressant trials that showed that children taking a range of
drugs had twice the rate of suicidal behavior and thinking compared
with those who took placebos.
The panel had to wrestle with a problem unique to psychiatry:
Depression is associated with suicide, and many specialists believe
the drugs reduce the risk.
While there is no conclusive evidence of this, studies have shown
that suicide rates dropped among populations of children as the
prescribing of antidepressants increased. Some experts believe the
medications, many of which belong to a class of drugs called
selective serotonin reuptake inhibitors, or SSRIs, may increase the
risk of suicide among some children while reducing it in others.
``If there were no SSRIs, would there be more suicides, fewer
suicides or the same number of suicides in children?'' panel member
Norman Fost, professor of pediatrics and bioethics at the University
of Wisconsin Medical School, asked at the start of Tuesday's
Robert Temple, the FDA's associate director for medical policy,
said there is no data to answer that question.
But most panelists agreed that the enthusiasm for the drugs among
U.S. physicians was not supported by the research. Many noted with
concern that with the exception of Prozac, none of the
antidepressants has been approved by the FDA for treating depression
in children. Most children are prescribed the medicines ``off
label'' -- based on physicians' belief that the drugs are safe and
effective. Once a drug has been cleared for the market, physicians
are free to use it even for conditions not specifically endorsed by
The panel's recommendation, on a 15-8 vote, left the FDA in the
potentially awkward position of having to warn physicians about
using the drugs for purposes that the agency has not approved.
The experts noted that although Prozac is the only drug
specifically approved to treat depression in children, the
top-selling antidepressant for youngsters is Zoloft. Two trials of
Zoloft failed to show the medication was superior to sugar pills in