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Depression and Anxiety Special Report

Antidepressant Warnings

Is the cure worse than the disease? Johns Hopkins psychiatrist Dr. Karen L. Swartz discusses the risks and benefits of SSRIs.

Call it the pill paradox: Some 20 years ago, selective serotonin reuptake inhibitors (SSRIs) burst onto the scene, lauded for their ability to treat depression. Today, however, some studies have linked SSRIs to an increased incidence of suicidal thoughts and behavior, and the U.S. Food and Drug Administration (FDA) is in the midst of an extensive review of drug safety data. This has led to what’s being called a “crisis of confidence” in antidepressants, with many people wondering whether antidepressants, especially SSRIs, are safe to take.

The controversy began with concern over the use of SSRIs in children and adolescents, with studies indicating an increased risk of suicide. For adults, the issue heated up recently, when researchers reported an increased risk of suicidal behavior during the first month of treatment with SSRIs. The study presented data on nearly 160,000 people treated in Britain with one of four antidepressants, two of which were the SSRIs fluoxetine (Prozac) and paroxetine (Paxil). The others were the tricyclic antidepressants amitriptyline (Elavil) and dothiepin (Dothep).

While the risk of suicidal behavior did not differ from drug to drug, the researchers found, it was elevated during the first month of antidepressant treatment and highest during the first nine days of treatment. It is important to note, however, that other studies have not found such a link. For instance, in another study in 2006, researchers analyzed drug safety data from that country’s regulatory agency. They found no evidence that SSRIs increase the risk of suicide. And a Swedish study found no link between SSRIs and an increased risk of suicide in either children or adults over a nine-year period. Moreover in the United States the suicide rate has actually declined since a peak in the late 1980s -- a drop that coincides with the introduction of SSRIs.

FDA Warnings on SSRIs

Because of the importance of this issue, the FDA is moving ahead with a safety review of antidepressant medications in adults, with the results expected later this year. In the interim, the FDA issued a public health advisory in July 2006 directed at adults. According to the advisory, adults who are being treated with antidepressants should be watched closely for worsening of depression and for increased suicidal thoughts or behavior. The FDA added that this increased surveillance might be especially necessary when a person goes on antidepressant medications for the first time or when doses are changed.

Where does all this leave us? It is essential to remember that serious depression poses a significant risk to a person’s life. The vast majority of people who commit suicide have major depressive disorder or bipolar disorder that is not being treated at all. Overall, SSRIs have a good safety profile, with fewer side effects than other antidepressants, which is why they are widely used. And beyond that, it is essential to remember that the real threat lies with the disease itself. If you are struggling with depression, get treatment. Untreated bipolar disorder and major depression kill people every year; their threat to your health is significant and should never be ignored or glossed over.

  • For more Depression & Anxiety articles, please visit the Depression & Anxiety Topic Page


    Posted in Depression and Anxiety on September 26, 2007
    Reviewed July 2009

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