Child Suicide Attorney Applauds Antidepressant Black Box Warning Mandate

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FDA ordered manufacturers of more than thirty antidepressants to include a black box warning on their labels explaining the drugs increase the risk of suicide in children and adolescents.

Today, the FDA ordered manufacturers of more than thirty antidepressants to include a black box warning on their labels explaining the drugs increase the risk of suicide in children and adolescents.

http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm.

Karen Barth Menzies, who represents dozens of children or their families related to antidepressant-induced suicides or suicide attempts and who testified at both Psychopharmacologic Drugs and Pediatric Advisory Committee hearings in Feb. and Sept. 2004 about the risk of suicide in children and adolescents, stated, “The black box warning is a huge milestone that would not have been achieved absent the collective and ceaseless efforts of courageous victims, scientists with the integrity to speak out (despite pressure from the pharmaceutical companies), the media, congressional representatives, and the advocates doing all possible to increase the awareness of this suicide and violence risk. This combined effort has finally forced the FDA to do what it should have done 13 years ago.

“FDA’s action should not end here, however. It still has yet to appropriately address the risk of these drugs causing hostility and violence, and that the suicide and violence risk exists for adults, as well. The FDA also significantly failed to adopt the Advisory Committee’s recommendation that the black box clearly notify physicians that these drugs have failed to demonstrate effectiveness.”

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Robin McCall
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