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<text id=90TT2008>
<title>
July 30, 1990: Warnings About A Miracle Drug
</title>
<history>
TIME--The Weekly Newsmagazine--1990
July 30, 1990 Mr. Germany
</history>
<article>
<source>Time Magazine</source>
<hdr>
MEDICINE, Page 54
Warnings About a Miracle Drug
</hdr>
<body>
<p>Reports of suicide attempts in Prozac users raise doubts about
the popular antidepressant
</p>
<p> A swift and sweeping popularity is often followed by a
stinging backlash. That is as true for medical therapies as it
is for hit TV series and fashionable restaurants. The latest
example: Prozac, a drug taken to combat depression. Introduced
in January 1988 and hailed as safer than competing medications,
Prozac quickly surged to star status, thanks to skillful
promotion by manufacturer Eli Lilly, glowing word of mouth
among doctors and patients, and heavy media attention,
including cover stories in Newsweek and New York. Sales are
expected to top $700 million this year, making Prozac the
leading antidepressant.
</p>
<p> Now, though, Prozac is receiving some unfavorable publicity.
Reports have surfaced that the drug can sometimes make users
feel suicidal--just the opposite of the desired effect.
Prozac "survivor" groups, which help people who say they have
had bad experiences with the drug, have been formed in New
York, Indiana, Florida, Iowa and Kentucky. And last week a
woman in New York State sued Eli Lilly for $150 million,
claiming that Prozac had induced her to slash her wrists.
</p>
<p> Despite the new concern, the evidence linking Prozac to
suicidal behavior is tenuous and relies mostly on anecdotal
histories. The most substantial report appeared last February
in the American Journal of Psychiatry. In that study, Dr.
Martin Teicher, a research psychiatrist at McLean Hospital in
Belmont, Mass., documented the cases of six depressed patients
who became obsessed with violent suicidal thoughts two to seven
weeks after starting treatment with Prozac. Four tried to hurt
or kill themselves. The compulsion subsided after the patients
went off the drug.
</p>
<p> But there were several confounding factors, as Teicher is
quick to admit. Four of the patients were on other medications
as well as Prozac. Five of the patients had contemplated
suicide or attempted it at some point in their past. That
raises the question of whether the preoccupation with
self-destruction resulted from Prozac or from the depressive
disease itself. Teicher suspects the drug in part because none
of the patients were actively suicidal at the time they began
therapy with Prozac. "Moreover," he observes, "the nature of
their suicidal thoughts was qualitatively different than it had
been in the past. While they were on medication it became an
irresistible impulse."
</p>
<p> Both Eli Lilly and the Food and Drug Administration point
out that Prozac was extensively tested on more than 5,600
patients and that at least 2 million people worldwide have
taken the drug. The FDA, which monitors reports of adverse
reactions to drugs, sees no worrisome pattern to date. "Even
if we got several hundred reports involving suicide and Prozac,
we wouldn't be alarmed, given how many people use the drug and
the nature of the disease," notes Dr. Paul Leber, director of
the FDA's division of neuropharmacological drug products.
"Depressed people commit suicide." Nonetheless, the agency is
watching closely, and Eli Lilly revised its product literature
in May to alert physicians to the suggested association with
suicide. "But we emphasize that there is no reason to believe
a cause-and-effect relationship exists," says company
spokeswoman Marie Abbott.
</p>
<p> There is no need for everyone to be scared away from Prozac,
since it has proved safe and effective for many people. But
some doctors fear that Prozac has been overprescribed. In the
initial excitement after its introduction, the drug was given
to patients to help them lose weight and stop smoking, despite
a lack of solid evidence that it is effective for those
purposes. The experience with Prozac underscores the truth
about drugs in general: they all carry risks and should be used
with care and restraint.
</p>
<p>By Anastasia Toufexis. With reporting by Andrew Purvis/New York.
</p>
<p>PROFILE OF A POPULAR PILL
</p>
<p>PROZAC
</p>
<p> Purpose: relieves depression.
</p>
<p> Sales: up from $125 million in 1988 to an estimated $700
million this year.
</p>
<p> Advantage: has fewer of the side effects, like hypertension
and constipation, associated with other antidepressants.
</p>
<p> Possible adverse reactions: insomnia, upset stomach and,
rarely, extreme agitation.
</p>
</body>
</article>
</text>