State Survey Finds FDA “Black Box” Warning Correlates with Curtailed Antidepressant Prescriptions
• Science Update
After the U.S. Food and Drug Administration (FDA) issued a “black box” warning on antidepressant medications, Nebraskan doctors began prescribing fewer antidepressant medications to children and teens and referring more patients to specialists, according to a state survey. The study, which involved NIMH-funded researchers, was published in the February 2008 issue of the Journal of Child and Adolescent Psychopharmacology.
The FDA announced the black box warning , which is the most serious type of warning a medication can carry, in October 2004. The warning alerted users of an increased risk of suicidal thoughts and actions among children, adolescents and more recently adults through age 24, who take the medications. Supriya Bhatia and Christopher Kratochvil, M.D., of the University of Nebraska Medical Center, and colleagues developed and administered a survey to Nebraskan clinicians in summer 2005 to gauge the warning’s impact on prescribing practices. Participants represented 140 communities and included general practitioners, pediatricians, psychiatrists (both child and adult), residents and fellows in training, nurse practitioners and physician assistants.
Of the 1,521 clinicians who received the survey, 57 percent responded. Among the respondents, 97 percent said they were familiar with the black box warning. About half reported feeling “moderately comfortable” or “comfortable” with prescribing antidepressants to children and teens, but few reported feeling “very comfortable.” The survey did not address clinicians’ comfort levels with prescribing antidepressants prior to the warning.
Although 77 percent had been prescribing antidepressants to children and teens before the warning, many reported writing fewer prescriptions for the medications after the warning was issued—15.5 percent curbed their prescriptions to children and 37 percent curbed their prescriptions to adolescents. In addition, 44 percent reported referring more of their patients to specialists, especially psychiatrists and other mental health professionals.
Respondents also reported that 22 percent had encountered caregivers or parents who refused antidepressant treatment for their children because of the black box warning. The survey did not address the rate of parental refusal prior to the black box warning.
Finally, the survey found that although 40 percent of the clinicians reported seeing patients more frequently once they began antidepressant treatment, only 7.5 percent said they saw their patients weekly for the first month, as recommended by the FDA. On average, respondents only saw their patients two times in the first month, including the initial visit.
Bhatia SK, Rezac AJ, Vitiello B, Sitorius MA, Buehler BA, Kratochvil CJ. Antidepressant prescribing practices for the treatment of children and adolescents . Journal of Child and Adolescent Psychopharmacology. 2008; 18(1): 70-80.