2006N-0414 Suicidality Data from Adult Antidepressant Trials
FDA Comment Number : EC29
Submitter : Dr. Susan Boyd Date & Time: 12/01/2006 09:12:18
Organization : University of Maryland School of Medicine
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I oppose having a black box warning about suicidality and SSRI medications. First of all, suicidality does NOT increase with taking SSRIs. A recent study has shown that suicidality DECREASES in the month following initiation of SSRI medication. Second, a black box warning is not necessary for monitoring of depressed patients. The standard of care is to evaluate suicidality at each visit for depressed patients. Finally, a black box warning unfairly attaches a barrier to the prescription of SSRIs, which overall are very safe medications that decrease morbitity for millions of patients who are or have taken them.