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Antidepressants' risk of suicide now called low
By Scott Allen, Globe Staff | January 1, 2006
The Food and Drug Administration warning two years ago seemed like a cruel irony: Antidepressants might make certain patients suicidal, the last thing anyone would expect from drugs so widely accepted as an antidote to the misery of depression.
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Sign up for: Globe Headlines e-mail | Breaking News Alerts But now, a large-scale, federally funded study suggests that the suicide fears may be largely unfounded. The study of 65,000 adults, adolescents, and children being treated for depression found that suicides were extremely rare and the number of serious attempts immediately dropped by more than 50 percent compared with the month before patients began taking antidepressants.
The bigger worry, said the authors of the suicide study published in today's American Journal of Psychiatry, is that antidepressants don't significantly help most people who have chronic depression. A separate major report in today's issue of the journal found that antidepressants brought complete relief to about 30 percent of patients who have recurrent bouts of depression -- and half saw no improvement at all.
''Keeping a close watch on patients after they begin taking these drugs is a good idea, although not because these medicines are especially risky or dangerous," said Dr. Greg Simon, a psychiatrist at Group Health Cooperative in Seattle and lead author of the suicide study. ''The real problem with antidepressants is that they don't work right away, they have side effects, and . . . unfortunately, doing miserably is common."
Simon's findings -- along with the long-awaited results on the drugs' effectiveness -- are likely to reshape the debate over antidepressants, the fifth-most popular medications in the country, with 122 million prescriptions written in the last 12 months. One in 16 Americans experience a major depression each year, causing about $31 billion a year in lost productivity from lost work time, and drugs such as Prozac, known as a selective serotonin reuptake inhibitor, have been the drug of choice to treat the epidemic.
But antidepressants have been under a cloud since March 2004, when the FDA cautioned that they may trigger agitation, anxiety, and hostility in some patients, possibly leading to suicide attempts, especially among people under 18. Since the FDA warning, antidepressant prescriptions have dropped 20 percent among adolescents. In July, the FDA announced it would conduct a new review of increased suicidal behavior in adults.
The Group Health study, which reviewed computer records for patients in a Washington state managed care plan, suggests the focus on suicidal behavior is overblown. Among 65,000 patients treated from 1992 to 2003, the researchers identified 76 suicide attempts requiring hospitalization in the six months after they went on antidepressants, including 31 that were successful. They found virtually the same number of suicide attempts -- 73 -- in the three months prior to treatment, which is half that time. That translates to a rate that is twice as high. And that doesn't count depressed people who committed suicide before ever taking antidepressants.
The pattern was the same among the 5,107 people under age 18 in the study: The number of serious suicide attempts dropped precipitously after they began taking antidepressants from 14 in the month before treatment to five in the month after. However, adolescents as a group are about four times likelier to attempt suicide than people over 18.
Further, Simon said, there is no evidence to support a widely held assumption among psychiatrists that patients can temporarily become more suicidal during the first few weeks they take antidepressants while their bodies get acclimated. He called that ''an urban myth" that fails to consider that depressed people are at an even higher risk of suicide when they get no help at all. Some studies have estimated that 15 percent or more of chronically depressed people ultimately die by suicide.
Dr. Robert Temple, medical policy director at the FDA, said the Group Health Cooperative results don't contradict what his agency has been saying about the potential risk of antidepressants. The FDA issued its warning based on 25 studies of 4,000 children that showed 109 experienced suicide-related behaviors such as self-cutting or making plans to commit suicide after taking the pills. However, none of the children killed themselves.
Temple said it could be that antidepressants trigger suicidal feelings in some patients, while not making them any likelier to actually follow through on a serious suicide attempt. In fact, he stressed that no study has documented an increase in suicides among people on antidepressants.
Still, Temple said, close monitoring of patients after they begin taking antidepressants makes sense, especially among adolescents who are more prone to suicidal behavior. He also noted that up to now, no clinical study has proven that antidepressants work in people under 18.
The second depression study in today's Journal of Psychiatry -- the first results from a six-year, $35 million, federally funded project -- tested the effectiveness of antidepressants far more rigorously than the studies drug companies carried out to get FDA approval.
Company-funded trials typically focus on short-term relief for people whose depression is not chronic or complicated, but the Sequenced Treatment Alternatives to Relieve Depression study -- known as STAR*D -- looked for full remission among people who had experienced an average of six bouts of major depression. Rather than treating these patients at a central location, the STAR*D researchers monitored patients at 41 clinics and doctors' offices across the country. The six-year study also was cited by the journal.
The researchers found that about 30 percent of these 2,876 chronically depressed people achieved full relief from symptoms after up to 14 weeks of taking Celexa, chosen as a typical antidepressant because it causes fewer side effects when people stop taking it. Another 10 to 15 percent of the patients got some relief, but everyone else -- more than 50 percent of the people in the trial -- saw no relief from depression at all.
Nonetheless, the researchers were encouraged at the success rate, noting that it matched the drug companies' success rates, which typically range from 25 to 40 percent, while working with tougher patients. Dr. Madhukar H. Trivedi of the University of Texas Southwestern Medical Center in Dallas, lead author of the STAR*D study, said doctors were able to boost the effectiveness of antidepressants by closely monitoring patients' response and adjusting the dose accordingly. The 30 percent remission rate, he said, ''is as good or a little better than we expected."
The STAR*D researchers also discovered that people who were well-educated, employed, married, white, female, or relatively healthy tended to get more benefit than average from taking Celexa. On the other hand, people with other medical problems or psychiatric disorders tended to get less benefit from the drug. For instance, 17 percent of people who also experienced hypochondria got relief from their depression from taking the drug.
''The real goal of STAR*D is how best to help the 70 percent of patients for whom treatment with a representative [antidepressant] is not enough for remission," said Dr. Thomas Insel, director of the National Institute of Mental Health, which paid for the STAR*D study. In the months to come, he said that additional studies will show how these patients fared when they were given other drugs or psychological counseling.
Scott Allen can be reached at allen@globe.com.
© Copyright 2006 Globe Newspaper Company. |
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