FDA Timeline on Issuing Warnings

October 27, 2003: The agency announces it will convene a special advisory committee, composed of members of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee, to examine the risk of suicidality associated with antidepressant use in pediatric and adolescent patients. A public-health advisory on this issue is distributed to all licensed U.S. physicians through the agency's MedWatch electronic notification system.

February 2, 2004: The meeting of the Psychopharmacologic Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee is held.

March 22, 2004: A Public Health Advisory urges clinicians to“ carefully monitor patients on antidepressants for possible worsening of depression or suicidality” without making a distinction between the risks for children and adults.

October 14, 2004: The FDA mandates a black-box warning on antidepressant drug labels to describe the increased risks of suicidality in children and adolescents.

June 30, 2005: In a Public Health Advisory the FDA announces ongoing review of data on increased suicide risks associated with use of antidepressants and cautions that “adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.”

May 2, 2007: The FDA again revises wording about the risk of suicidality in product labels of antidepressants. While the warning is expanded to include young adults, the language for adults is changed to state that“ short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared with placebo in adults aged 65 and older.”