Antidepressant safety labeling impact
Executive Summary
A Medco study finds that less than 15% of patients on antidepressants receive the FDA recommended level of follow-up care in first four weeks of treatment, 18% at eight weeks and 23% at 12 weeks. The findings, which appear in the August issue of the American Journal of Managed Care, reviewed 84,500 pediatric and adult patients who started a new course of antidepressant therapy between July 2001 and September 2003. The study revealed that 66% of children and 83% of adults had no follow-up visits during the first month of treatment; FDA recommends weekly in-person visits with a health practitioner during that period. FDA required the antidepressant class to add a "black box" warning on suicidality in 2005 (1"The Pink Sheet" Jan. 17, 2005, p. 3)....