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FDA Asks Antidepressant Makers To Warn Adults About Suicide RisksBy JENNIFER CORBETT DOOREN
WASHINGTON - The Food and Drug Administration said Wednesday it was expanding a “black box” warning on antidepressants stating that the drugs appear to increase the risk of suicidal thinking in young adults up to age 25. The current warning states that antidepressants increase the risk of suicidal thinking and behavior in children and adolescents and doesn’t include an age limit. The FDA said it was asking makers of antidepressant medications to update the black-box to discuss “increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment.” The FDA said initial treatment period is typically one to two months. The agency said, however, it would also update the warning to state that “depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.” The FDA said there doesn’t appear to be an increased suicidality risk in adults older than 24 and that in adults ages 65 and older “taking antidepressants have a decreased risk of suicidality.” In December, the FDA proposed updating the black-box warnings on antidepressants after reviewing data from 372 clinical studies involving 11 antidepressants, including GlaxoSmithKline PLC’s Paxil, Pfizer Inc.’s Zoloft and Eli Lilly & Co.’s Prozac. The agency said it reviewed the studies, which involved about 100,000 patients, to look at the impact on suicide risk. The FDA review found a “differential risk of antidepressant-induced suicidality across the age spectrum” with the risk of suicidal behaviors being at the younger end of the spectrum and that it declined with age with a greater “protective” effect in adults aged 65 and older. Suicidality refers to thoughts about suicide or suicidal behaviors and not completed suicides. Write to Jennifer Corbett Dooren at Remember You? Send comments to Your E-mail? Verification Code:
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