Pharmaceutical Business review

Report suggests benefits of antidepressants outweigh risks

The American College of Neuropsychopharmacology (ACNP) produced a so-called Task Force Report evaluating the safety and efficacy of selective serotonin reuptake inhibitor (SSRI) antidepressant medication for depressed youths under 18 years of age. Antidepressant medications, including SSRIs, have been proven effective for treating depression in adults, and while this effect may also generalize to youth, it has received less study.

The report was undertaken by the ACNP after regulatory agencies raised concerns about the possibility that treatment of depression with SSRIs in that age group might increase the risk of suicide. In September 2004, the FDA decided to require a black box warning regarding suicide risk for all antidepressants, continuing the debate on the efficacy and relative risk of antidepressant use in youth with depression.

The ACNP Task Force Report urges clinicians treating depressed youth to ask about suicide, suicidal thinking, and plans for suicide, and noted that ongoing monitoring of suicidal thoughts in patients treated with antidepressants is necessary.

The report concluded that the available data from clinical trials of SSRIs and other new generation antidepressant medications indicate a small increase in the risk of adverse event reports of suicidal thinking or suicide attempts in youth (2% vs. 4% on average). However, no suicides have occurred in the FDA database of trials of antidepressants in youth. Furthermore, the FDA analysis of systematic ratings of suicidal ideation and behavior in these antidepressant studies of depressed youth did not find an increased risk of a worsening of those thoughts or behaviors among those taking SSRIs vs placebo.