An FDA advisory committee of independent experts recently voted 15 to 8 to add a "black box" warning to the packaging information of all antidepressants concerning the risk of increased suicidal tendencies in children and adolescents. Following review, the FDA stated that it "generally supports the recommendations" of the advisory committee (http://www.fda.gov/bbs/topics/news/2004/NEW01116.html).
The broadly worded recommendation applies to all antidepressants, including newer selective serotonin reuptake inhibitors, as well as older drugs, such as tricyclics.
An FDA analysis of clinical trial results found that 2% to 3% of children who took the drugs displayed suicidal thoughts or behaviors that could potentially be tied to the medications. Yet the cause of the risk remains unclear, and no children in the trials actually committed suicide.
Committee members who opposed requiring a black box warning expressed concern that it would dissuade some physicians from treating children with depression, which . . . [Full Text of this Article]
