Changes to Black Box Warnings for AntiDepressants Proposed
Drug Manufacturers Have 30 Days to Submit Revised Labels to FDA
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- Suicidality
On May 2, 2007, the FDA proposed updated black box warnings on all antidepressant medications to include notifications about the increased risk of suicidality in young adults aged 18 to 24 during initial treatment. The proposed labeling change is the result of a comprehensive review of suicidality in 295 individual antidepressant trials of adults with major depressive disorder and other psychiatric disorders taking antidepressants.
The risk of suicidality, or suicidal thinking and behavior, was found to be twice as high among patients aged 19 to 24 in the studies than in adults the same age who took placebo pills. The labeling change proposal follows similar changes made by the agency in 2005 that warned of an increase risk of suicidality in children and adolescents who use antidepressants. At that time, the FDA mandated the addition of the black box warning, considered the strongest warning possible. A “black box” is a bolded black box that appears at the top of a prescription drug warning pamphlet and indicates side effects that may cause serious personal injury or death.
Manufacturers of antidepressants must also develop updated Medication Guides for new patients that include the updated warnings. The FDA also recommends manufacturers remind doctors to balance the risk of increased suicidality in younger populations with the clinical need for antidepressive treatment and to include mention that antidepressants do not appear to increase suicide risk in patients older than 25, and even reduce the risk in patients older than 64. This mixed-message appears to reflect the ongoing debate on the effectiveness of antidepressants, which can actually increase depressive feelings during initial course of treatment.
Dr. David Healy, psychiatrist at the University of Cardiff in Wales, says the updated warnings are long overdue. “The clinical trial data pointing to a risk was compelling 17 years ago,” Healy told the New York Times. About 11 percent of American adults younger than 44 received at least one prescription for an antidepressant medication in 2006.
Sources: Benedict Carey, “F.D.A. Expands Suicide Warning on Drugs,” New York Times, May 3, 2007; U. S. Food and Drug Administration, Release #P07-77, May 2, 2007.
