FDA Approves "Black-Box" Warning for Antidepressants
by Guest Blogger, 10/18/2004
FDA approved the "black-box" warning for antidepressants last Friday. The warning will alert doctors and patients to the increased risk of suicidality for children using antidepressants. The "black-box" warning is the highest level of warning FDA uses. In approving the new labeling, FDA followed the recommendations of both its advisory panel and a congressional committee, both of which called for the "black-box" label. The label comes amidst a controversy as to FDA's role in alerting the public to the dangers of child use of antidepressants.