Antidepressant warnings could include adults
NEWS IN BRIEF — Posted Jan. 15, 2007
Black-box warnings about suicide risk for children who take antidepressants may soon be broadened to include adults up to age 25. Warnings of the suicide risk posed by the drugs to children were added in 2004.
A Food and Drug Administration advisory committee voted Dec. 13 to recommend that the warnings be changed to reflect agency data on suicidal behavior gathered from 372 placebo-controlled trials with a total enrollment of nearly 100,000 people.
There was not enough information on completed suicides in the database to indicate whether any talk of suicide or suicide attempt had actually resulted in a death, said the agency.
The panel also recommended that the medication labels carry information on the risks posed by untreated depression. Many who testified before the panel expressed concern that the warnings might discourage the use of a treatment that is effective at treating depression.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/01/15/hlbf0115.htm.