making her well, woman says drug sent her ... Spinning Out of
||Monday, October 18,
Sevastianenko is suing the maker of Paxil claiming the
anti-depressant drug made her suicidal. (Paul
Fraughton/The Salt Lake Tribune)
THE SALT LAKE
Victorovna Sevastianenko, a Utah college student from the
former Soviet republic of Belarus, had severe stomach pains.
But a doctor and nurse practitioner thought the discomfort
might be a symptom of depression.
all, their patient was thousands of miles from home and alone
in a foreign country.
The medical staff
recommended she take the anti-depressant Prozac. After a
series of phobic episodes and fainting, the staff changed the
prescription to a related drug, Paxil. That was when
Sevastianenko said she began to think about suicide. She made
five attempts on her life and was haunted by obsessive,
irrational thoughts about hurting her boyfriend and others.
Now, Sevastianenko is suing the
pharmaceutical company that produces Paxil for failing to
provide "proper, honest [and] candid warnings."
"There is a small but recognized group
of people who will have this reaction," said Edward Havas, one
of two attorneys representing Sevastianenko in Salt Lake
City's U.S. District Court. "[SmithKline Beecham Corp.], the
company that makes Paxil, has used a broad-based and
consumer-oriented marketing strategy that has been very
successful -- they have made billions of dollars. But with
that success comes a responsibility to warn consumers and
doctors about possible negative side effects."
It is true that SmithKline Beecham, a
London-based company with U.S. headquarters in Philadelphia,
is valued at more than $70 billion and has been prospering.
But that does not mean the corporation has been irresponsible,
says company spokesman Brian Jones.
"Paxil does not cause suicide," said Jones. "Depression causes
Michael Stevens, medical
director for Valley Mental Health and a psychiatrist, said he
has not seen a direct connection between anti-depressants and
suicide. But Stevens said serious adverse side effects are a
reality with most drugs.
certainly not inconsistent with our knowledge of what these
medicines do, how they work in the body," he said. "SSRIs as a
class have been enormously helpful, but the problem is that a
very, very small number of people will develop negative side
Paxil, one of the drugs known
as selective serotonin-reuptake inhibitors, or SSRIs, was
approved by the Federal Drug Administration in 1991. The
anti-depressant, recently approved by the FDA for treatment of
social anxiety disorder, also has been used to treat a range
of other mood and anxiety disorders.
According to SmithKline Beecham, Paxil has the FDA's blessing
to treat more conditions than any other anti-depressant. The
company estimates doctors have prescribed the drug to more
than 60 million patients worldwide for treatment of
depression, panic disorder and obsessive-compulsive disorder.
But the number of satisfied customers
does not matter to Sevastianenko.
couldn't say my life was easy -- I was a 19-year-old foreign
student without my parents," Sevastianenko said. "But I had
lived for many years with the idea of coming to the United
States. For me it was a victory."
1997, three months after having adverse reactions to Prozac,
Sevastianenko began taking Paxil and that, she says, is when
the nightmare began.
"The first thing I
noticed was a weird feeling of not quite knowing if I was
awake or asleep," Sevastianenko said as she twisted a tissue
between her fingers. "If you're driving, you don't care if you
get in an accident. You constantly have to touch things to
know if they're real."
Then came the
bad dreams, the anxiety and an inability to concentrate.
Sevastianenko said she would go to the library to study, only
to find herself rereading the suicide scene from Leo Tolstoy's
"I was obsessed with
killing myself," Sevastianenko said. "There was no logic
Sevastianenko told her
shocked boyfriend she was feeling suicidal. They talked for
five hours and she said she felt better. The next day, she
broke a jar and cut her wrist with a shard of glass.
Her boyfriend took her to the emergency
room, but a psychiatrist could not see her for three days.
Meantime, the suicidal feelings
worsened, Sevastianenko said. Her boyfriend and a friend took
turns being with her in a 24-hour suicide watch. Sevastianenko
said her boyfriend had to restrain her to keep her from
running in front of passing cars or harming someone.
"It's hard when you walk down the
street, you see someone and say to yourself, 'I don't like
him. I don't like what he's wearing. I want to butcher him,'"
By the end of last
October, she was in the hospital for a three-week stay. In
December, she stopped taking SSRIs and went home to Belarus,
joined by her boyfriend, who is now her fiance.
When she returned to Utah in March
1998, she said she was "back to normal." Then Sevastianenko
and her boyfriend, a graduate student in bioengineering at the
University of Utah, asked themselves about her suicidal
"Suicide had never occurred
to me before taking Paxil," Sevastianenko said. "I had been
normal. Happy. Looking back it was so scary. It was like I
wasn't quite there."
alleges in her lawsuit that SmithKline Beecham did not give
sufficient warning about the potential suicide side effect and
failed to "test for this phenomenon, to investigate other
suicides by people on SSRI and to warn both physician and
In cautions to physicians,
the company warns about many possible side effects, including
insomnia, dizziness and nausea. The prescribing information
also notes: "The possibility of suicide is inherent in
depression and may persist until significant remission occurs.
Close supervision of high-risk patients should accompany
initial drug therapy."
research indicates that a small percentage of people taking
anti-depressants from the SSRI drug family experience serious,
life-threatening side effects. Paradoxically, after taking
SSRIs to feel better, they become obsessed with the idea of
A 1990 article in
the American Journal of Psychiatry detailed case histories of
patients who, although depressed, had never experienced
"suicidal ideation," or thoughts of suicide, before taking
"Rather, all were hopeful and
optimistic," wrote authors Martin Teicher, Carol Glod and
Jonathan Cole. But after taking SSRIs "two patients
fantasized, for the first time, about killing themselves with
a gun, and one patient actually placed a loaded gun to her
head. One patient needed to be physically restrained to
prevent self-mutilation. [Another patient], who had no prior
suicidal thoughts, fantasized about killing himself in a gas
explosion or a car crash."
patients stopped taking the SSRIs, the suicidal feelings
In the authors' clinical
experience, about 3.5 percent of their patients demonstrated
suicidal tendencies after taking SSRIs. Although the
health-care professionals argued there were no simple
explanations for the occurrence of suicidal feelings, they
warned medical professionals to "query patients carefully
about suicidal ideation, particularly if they are not
responding well to treatment."
also limited, more recent research suggests a link between
suicidal ideation and SSRIs. A 1998 article by Roger Lane in
the Journal of Psychopharmacology notes that some patients on
SSRIs may feel that "death is a welcome result" when other
adverse effects from the anti-depressant are sufficiently
But a problem with the narrow
research is that few outside the mental-health field read the
scientific literature. About 75 percent of SSRIs are
prescribed by medical doctors, not psychiatrists. Many
doctors, said Valley Mental Health's Stevens, simply do not
have the time to read the articles on suicides linked to
And although virtually all the
data on depression indicates patients respond better when they
are receiving both medication and therapy, not everyone can
see a psychiatrist or therapist.
"Talking therapy of many sorts can actually change the brain
chemistry," Stevens said. "There usually aren't any medical
side effects. The down side is that it is gradual."
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