Why do antidepressants have a Black Box Warning?
In October 2004, the FDA required a special warning (“Black Box Warning”) for all antidepressants. The FDA had conducted a review of the clinical trials of antidepressants and had concluded that, although no suicides occurred in these trials, there was an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants compared with those taking a placebo (sugar pill). A Black Box Warning does not mean that antidepressants are prohibited in younger patients, but instead encourages healthcare professional to balance this risk of increased suicidality with the benefits of treatment. The Black Box Warning also states that depression itself can cause suicidal thinking or behavior. The Black Box Warning emphasizes the need for close monitoring of patients, especially during the first few months of treatment and at the time of dose changes.
