2006N-0414 Suicidality Data from Adult Antidepressant Trials
FDA Comment Number : EC31
Submitter : Dr. Bernard Fischer Date & Time: 12/01/2006 09:12:39
Organization : Dr. Bernard Fischer
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am a psychiatrist practicing in Maryland. I am in total support of the FDA's mission keeping the American Public safe regarding medications, but I would discourage the FDA from mandating a black boxed warning on antidepressants for adults. Adding a black boxed warning would initially discourage some prescribers from using the medication or those with depression from taking the medication- leaving many individuals with depression untreated. Untreated depression, in turn, results in more suicides and morbidity. More morbidity can, in turn, result in loss of productivity for the economy. Furthermore, the decisions to use black boxed warnings without adequate scientific data eventually will result in loss of meaning for the warning. I implore you to judiciously use the black boxed warning and to refrain from using it in the case of antidepressants and adult suicide. Instead, the FDA should support the careful doctor-patient discussions and monitoring that are already the standard of care for use of these sometimes life-saving medications.