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While suicide is already mentioned in a rarely read portion of a
sheet included with prescriptions for the antidepressants, the new
discussion of suicide will be placed in the drug's warning section,
the most important, widely read and prominent section of the label.
To further ensure that doctors will read the material, part of it
will be in boldface. The label is the primary way the F.D.A.
communicates with physicians about the safety and efficacy of
Jennifer Yoder, a spokeswoman for Lilly, said the company would
comply with the agency's request.
"It's important that patients keep today's announcement from the
F.D.A. in perspective," Ms. Yoder said. "Depression is a serious
public health issue, and it takes great courage for patients to
begin treatment in the first place."
Dr. Catherine Clary, a Pfizer vice president, said the company
would work closely with the agency to come up with label changes for
Zoloft. A spokeswoman for GlaxoSmithKline, the maker of Paxil, said
the company was studying the request. The companies are almost
certain to adopt the agency's proposed changes.
While the F.D.A. does not have the power to require the changes,
if the manufacturers refuse to go along, the agency can declare
their drugs mislabeled and force their removal. Because every
antidepressant introduced in the past 15 years is included in the
warning, no company is at a disadvantage. Indeed, even drugs like
the GlaxoSmithKline antidepressant Wellbutrin, also known as Zyban,
that have not been linked with suicide were included.
The drugs in the warning are: Prozac; Zoloft; Paxil; Wellbutrin;
Luvox, from Solvay; Celexa and Lexapro, from Forest Laboratories
Inc.; Effexor, from Wyeth; Serzone, from Bristol-Myers Squibb; and
Remeron, from by Akzo Nobel.
The dispute about whether popular antidepressants cause some
patients to become suicidal or violent has been continuing for 14
years. In 1990, a Harvard psychiatrist wrote a paper suggesting that
some of his patients had become acutely suicidal after taking
Prozac. More testimonials followed. But a 1991 scientific advisory
panel concluded that there was no convincing evidence.
The studies in children raised the issue again last year, and
health authorities in Britain told physicians that with the
exception of Prozac, the drugs should not be used in teenagers or
children. Still, studies show that teenage suicides have declined
sharply in countries where antidepressant therapy has become
widespread, suggesting that the drugs prevent many more deaths than
they may cause.
Dr. Madhukar Trivedi, director of the mood disorders program at
University of Texas Southwestern Medical School at Dallas, said he
worried that the new warnings might make depressed patients afraid
of their pills. "The consequences for not treating depression are
very high," Dr. Trivedi said.
The agency advisory says: "Health care providers should carefully
monitor patients receiving antidepressants for possible worsening of
depression and suicidality, especially at the beginning of therapy
or when the dose either increases or decreases."
Anxiety, agitation, panic attacks, insomnia, irritability,
hostility, impulsivity and severe restlessness are also possible
side effects, the advisory adds.
The agency decided against following British regulators in
suggesting that physicians should avoid the drugs' use in children.
Only Prozac has been shown to be effective in treating depression in
children, but that does not mean the other drugs do not work,
"What we don't know for sure is what is the best thing to do for
a child who's depressed," Dr. Temple of the F.D.A. said. "Depression
has its own liabilities. It can be a fatal illness. What we don't
know is whether the long-term benefits outweigh the risks."