The Salt Lake Tribune -- Instead of making her well, woman says drug sent her ... Spinning Out of Control

Instead of making her well, woman says drug sent her ... Spinning Out of Control

Monday, October 18, 1999

Natalia Victorovna Sevastianenko is suing the maker of Paxil claiming the anti-depressant drug made her suicidal. (Paul Fraughton/The Salt Lake Tribune)

BY SHAWN FOSTER
THE SALT LAKE TRIBUNE

    Natalia 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.
    After 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 suicide."
    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.
    "It is 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 effects."
    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.
    "I 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."
    In 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 Anna Karenina.
    "I was obsessed with killing myself," Sevastianenko said. "There was no logic anymore."
    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,'" Sevastianenko said.
    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 feelings.
    "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."
    Sevastianenko 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 patient."
    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."
    Some medical 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 killing themselves.
    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 SSRIs.
    "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."
    After the patients stopped taking the SSRIs, the suicidal feelings disappeared.
    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."
    Although 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 severe.
    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 SSRIs.
    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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