FDA Committee Decides Not to Extend Black Box Warning to All Age Groups, Recognizes Untreated Depression as Major Risk for Suicide
A Statement by David Shern, Ph.D., President and CEO of Mental Health America
Contact: Heather Cobb (703) 797-2588 hcobb@mentalhealthamerica.net
ALEXANDRIA, Va. (December 13, 2006) — As president and CEO of the nation’s leading non-profit addressing the mental health of all Americans, I am pleased that the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee chose not to extend the black box labeling on antidepressants to all adults.
However, today, the Committee voted to extend the existing pediatric black box label on all antidepressant medications to age 25, citing data from the FDA’s recently completed meta-analysis. All committee members who voted for modified labeling agreed to do so only with the caveat that the labeling address the inherent risk of suicide in untreated depression – listening to the concerns of the leading national mental health and suicide prevention organizations in its Open Letter on Antidepressants to the FDA. To view the letter, go to wwww.mentalhealthamerica.net.
Mental Health America has serious concerns about the public health impact of this warning label. Since the black box warning went into effect in 2004 for children and youth, there is emerging data indicating that treatment and identification rates for depression have dropped. This labeling – and its new parameters – could further add to the formidable barriers for people of all ages in getting the help they need and recovering from their illness. As is well known, 90 percent of suicides are attributed to untreated or undertreated depression.
Mental Health America strongly encourages the agency to conduct an analysis of the impact of the black box label put in place in 2004 on rates of identification and treatment of depression and incidence of suicide. In addition, we are committed to working with the FDA and other federal agencies to ensure that there is better information for and monitoring of people taking medications.
Mental Health America is the country’s leading nonprofit dedicated to helping ALL people live mentally healthier lives. With our more than 320 affiliates nationwide, we represent a growing movement of Americans who promote mental wellness for the health and well-being of the nation – everyday and in times of crisis.
