AACAP: Black Box Warnings Decreased Pediatric Antidepressant Use

October 27, 2006

SAN DIEGO -- The black box warnings ordered by the FDA on the risk of suicidality with pediatric antidepressant use cut overall prescriptions for children and adolescents by some 10%, researchers said here.

SAN DIEGO, Oct. 27 -- Pediatric antidepressant prescriptions decreased by about 10% following black box warnings ordered by the FDA on an increased suicidality risk for these medications, researchers said here.

That decrease, which appeared to be mainly due to fewer new prescriptions, took place in the year after the warnings, according to the study reported at the American Academy of Child and Adolescent Psychiatry meeting.

"While not intended to discourage appropriate prescribing, concerns have arisen that the warning would result in hesitance to use potentially effective treatments," said Christine Thomason, Ph.D., of i3 Research in Basking Ridge, N.J., in a poster presentation.

The FDA found an increased risk for suicidal thoughts or behavior (average risk 4% versus 2% placebo) associated with some antidepressants, particularly SSRIs, and in October 2004 directed manufacturers to warn prescribers.

In the year after the warnings compared to the year before the warnings, the findings were:

  • Overall prescriptions decreased by 9.7% (68,121 versus 61,561, P

Interestingly, the frequency of office visits increased from an average of 11.7 per year to 12.1 per year (P