ETHESDA, Md., Sept. 14 - Federal drug regulators
should warn physicians and patients in the strongest possible terms
that antidepressants not only cause some children and teenagers to
become suicidal but most have also failed to cure their depression,
a federal advisory committee voted Tuesday.
The committee voted 15 to 8 that the Food and Drug Administration
should mandate that the drugs contain "black box" warnings on the
sheet of information that physicians review when prescribing drugs.
This type of warning is in boldface type, surrounded by a black
border and placed at the top of a drug's warning label.
"A black box is the strongest emphasis on warning information
that we know how to do," said Dr. Robert Temple, director of the
agency's office of medical policy.
After two days of testimony about the risks and benefits of the
pills, the committee also agreed unanimously that the agency should
require pharmaceutical manufacturers to attach a patient guide to
the drugs' packaging that would describe the risks of suicide in
plain language. Hundreds of approved drugs have black-box warnings,
but fewer than 30 are required to have such patient attachments,
F.D.A. officials said.
Children and teenagers who take antidepressants are twice as
likely as those given placebos to become suicidal, according to
studies presented to the committee. Still, the overall risk of
suicide is low. If 100 patients are given the drugs, 2 or 3 more
will become suicidal than would have had they been given
placebos.
The agency is not required to follow the advice of its advisory
committees, but it usually does. The committee could have
recommended banning the use of antidepressants by children and
teenagers, as British regulators did in December. But no one on the
committee strongly advocated such a step and even critics of the
drugs seemed torn about whether such action was needed.
The suicide risk, however small, appeared to concern some
committee members, mainly because the benefits of the medications
are unclear at best. Most of the drugs failed in studies to
ameliorate the symptoms of depression in teenagers and children. One
large study found that Prozac was effective in youngsters but not by
much. And with little benefit to recommend the medicines, some
committee members said that any risk was all but unacceptable.
"We have very good evidence of harm and very little evidence of
efficacy," said Dr. Thomas Newman, a professor of epidemiology and
pediatrics at the University of California, San Francisco. "It would
not be that bad if the use of these drugs declined, because it's
very unclear that they work."
Even after months of controversy about the links between
antidepressants and suicide, such a decline has yet to materialize.
In 2002, the last year for which total figures are available,
doctors wrote nearly 11 million prescriptions for the pills to
teenagers and children. That represented almost 8 percent of all
antidepressant prescriptions.
After the F.D.A. mandated in March that manufacturers state on
drug prescription sheets that they may be linked to suicide,
prescriptions of the drugs for youngsters continued to climb by
nearly 8 percent, the committee was told.
Some committee members said that such prescribing habits have
been driven by advertising. Pfizer, for instance, spends millions of
dollars advertising Zoloft, its huge-selling antidepressant.
If the F.D.A. follows the committee's recommendation by mandating
a black-box warning, however, Pfizer's advertisements, which feature
a cartoon head in obvious distress, will have to mention the risk of
suicide.
Susan Bro, a Pfizer spokeswoman, said that it was too early to
speculate on how such a requirement might affect the company's
advertising. Ms. Bro said that Pfizer shared "the F.D.A.'s concern
for this vulnerable patient population and for the devastating
impact of untreated depression."
Pfizer failed in two tests to prove that Zoloft effectively
treats depressed teenagers and children, but doctors prescribe
Zoloft to youngsters more often than any other antidepressant.
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