Antidepressants Unrelated to Suicide Risk

Antidepressants do not raise the risk of suicide, according to a large, population-based study-in contrast to US government-mandated warnings to the contrary.

The study, involving > 65,000 children and adults who receive treatment for depression over ten years, was published in the January issue of the American Journal of Psychiatry and reported by MedPage Today on 3 January 2006.

The observational study of patients enrolled in the Group Health Cooperative showed that suicide risk declines, rather than rises, after a person starts taking antidepressants, according to author Gregory E Simon, MD, MPH, a psychiatrist with the Group Health Cooperative, a Seattle-based non-profit health care organization.

Researchers also found that suicide risk was highest in the month before people started taking medication, fell by >50% in the month after starting medication, and progressively declined thereafter.

FDA Warnings Controversial

The American Journal of Psychiatry is published by the American Psychiatric Association (APA), which according to MedPage Today has previously criticized the FDA warnings about the possibility of increased suicide risk in children and adolescents associated with treatment with newer antidepressants.

Although the FDA continues to back these warnings, it will include the results of the study in an upcoming comprehensive review of safety data on adults' use of antidepressants, said Paul Seligman, MD, director of the FDA office responsible for post-marketing drug surveillance, according to MedPage Today.

Issued in October 2004, the FDA warnings were based on a meta-analysis of 24 pediatric trials of various antidepressants that included >4,400 patients. This analysis showed that people taking antidepressants had an increased risk of suicidal thinking and suicidal behavior during the first few months of treatment (4%), compared with people taking placebo (2%). None of the participants committed suicide.

The study by Simon et al differed from the FDA analysis in that the latter did not compare the risk of suicide before treatment with the risk after treatment, Dr Simon and colleagues reportedly said. In contrast, the current study examined suicide risk from three months prior to treatment through six months post-treatment.

Since the FDA warnings were issued, the APA has expressed concern that they might prevent people who need antidepressant treatment from accepting it, because of exaggerated fears about suicide risk. In September, the APA reported that antidepressant prescribing-rates had declined by 20% for patients 18 and younger since the FDA issued their warnings.

Simon et al's study "challenges the FDA warning that suicidal behavior may emerge after treatment is begun with antidepressant medications," an APA statement said, according to MedPage Today.

Clinical Trial Results

In the month prior to starting treatment, when suicide risk was highest, the suicide-attempt rate was nearly 100 per 100,000 treatment episodes. This rate decreased to < 50 attempts per 100,000 during the first treatment-month and continued to decrease thereafter, according to the authors, who suggest that this pattern may reflect depressive symptoms reaching a critical point that prompted therapy and improved thereafter.

During the first month of treatment, people treated with newer antidepressants had a suicide risk not significantly higher than during the next five months. Among those who received older drugs, the suicide risk was significantly higher during the first month of treatment, compared with the next five months. The researchers suggest this is because older drugs take longer to work-not because they increase suicide risk.

The FDA's Dr Seligman noted that the new study "reaffirms that the [suicide] risks are generally small" and gives a more thorough picture than a clinical trial, as suicidal patients are often excluded from clinical trials.

Pending the FDA's comprehensive review of clinical trial safety data in adults (which will take at least one year), the FDA is continuing to advise physicians carefully to monitor people receiving antidepressants for worsening of symptoms or increased suicidal thinking and behavior, Dr Seligman said to MedPage Today.

Dr Simon agreed with the FDA's recommendation, saying, "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," according to the MedPage Today report. "Patients need to be monitored to ensure they're getting the right medication in the amount that can help them feel better."

"There may be subgroups of people who become more agitated or suicidal after taking these drugs, and those people should seek help from a doctor or therapist right away if that happens," Dr. Simon said to MedPage Today. "But our study showed that on average, the risk of suicide actually goes down after people start taking the antidepressant."

Sources:
Antidepressants Found Unrelated to Suicide Risk, MedPage Today, 3 January 2006.
Suicide risk during antidepressant treatment. Simon GE et al, American Journal of Psychiatry, volume 163, pages 1-7, 2006.

Posted: February 2006


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