APA Welcomes FDA Antidepressant Label Changes Saying That Untreated Depression Is Greatest Risk Factor For Suicide

Today, the American Psychiatric Association (APA) welcomed labeling changes from the Food and Drug Administration (FDA), which apply to antidepressant use in adults. The FDA's new labeling acknowledges, for the first time, that untreated depression puts people at risk for suicide. The FDA label will continue to offer guidance on antidepressant treatments and suicidal thoughts and behaviors, sometimes referred to as "suicidality." While the medications are generally acknowledged to protect against completed suicides, some analyses, notably of younger patients, raise concerns about small increases in reports of suicide-related thinking and behaviors. In response to the FDA announcement, Carolyn Robinowitz, M.D., president-elect of the APA, issued the following statement: "We welcome today's announcement from the FDA as a major step in the right direction. Specifically, we are pleased that the agency is changing the label on antidepressants to acknowledge, for the first time, that it is untreated depression that puts people at the greatest risk for suicide. This change in labeling is supported by the science. The agency clearly heard its own advisors - the Psychopharmacologic Drugs Advisory Committee - and physicians and patients, all of whom came together at a hearing last Dec. 13 to tell the agency what labeling would best meet patients' needs. While some participants at that hearing called for drastic labeling changes that would have further restricted access to these lifesaving medications, the FDA wisely acted in patients' best interests. Studies have shown that the old labeling - a black box warning label that the agency had issued in 2004 - was associated with a steep decline in treatment rates. Worse, the 2004 labeling change was followed by an increase in the suicide rate, reversing a decade-long decline in suicide deaths in the United States. We believe the new label, which still contains important warning information, reminds physicians and patients that antidepressants save lives. Physicians and patients need all the facts in order to make appropriate, informed decisions about any proposed course of treatment. Finally, we continue to encourage the FDA to formally monitor the effects of its labeling changes." About the American Psychiatric Association The American Psychiatric Association is a national medical specialty society whose more than 38,000 physician members specialize in diagnosis, treatment, prevention and research of mental illnesses including substance use disorders. Visit the APA at

(Author: www.psych.org)

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