Regulatory warnings regarding the risk of suicidal thoughts and behaviors appear to be associated with reductions in the number of antidepressant medication prescriptions among children and adolescents covered by Tennessee's expanded Medicaid program.
Antidepressant medications are frequently used to treat depression among children and teens, but in 2003 data emerged regarding an increased risk of suicidal thinking and behavior among young patients taking these drugs, according to background information in the article.
"In December 2003, the Committee on Safety of Medicines [the U.K. drug regulatory agency] declared the risk-benefit profile of all selective serotonin reuptake inhibitor (SSRI) antidepressants (as well as venlafaxine hydrochloride and mirtazapine), with the exception of fluoxetine, to be unfavorable for the treatment of major depressive disorders in children and adolescents," the authors write.
"Shortly thereafter in 2004, the Food and Drug Administration convened a Psychopharmacology Advisory Committee meeting in February, issued a public health advisory in March, and in October required black box warning labels for all antidepressants (including fluoxetine) highlighting the potential increase in suicidal thinking and behavior in children and adolescents.
The warning recommended more intense therapeutic monitoring to mitigate these risks but did not suggest avoiding the pediatric use of antidepressants."
Benji T. Kurian, M.D., M.P.H., and colleagues at Vanderbilt University School of Medicine, Nashville, Tenn., examined monthly antidepressant prescription data among patients age 2 to 17 years covered by the TennCare expanded Medicare program. "The study included the 45 months from Jan. 1, 2002, through Sept. 30, 2005, 12 months following the FDA black box warning," the authors write.
"The study months were divided into two periods. The period before the regulatory warnings included the 24 months from Jan. 1, 2002, through Dec. 31, 2003, and that after the regulatory warnings included the 21 months from Jan. 1, 2004, through Sept. 30, 2005." An average of 405,000 children and teens qualified for the study each month.
During the period before the regulatory warnings, there was little change from month to month in the rate of new antidepressant prescriptions, with an average of 23 per 10,000 patients. By the end of the study—a total of 21 months after the U.K. warnings—this proportion had decreased by 33 percent to an average of 15 per 10,000 per month.
The decrease was most pronounced for SSRIs (except for fluoxetine) and another type of antidepressant linked to suicidal thoughts and behaviors, selective norepinephrine reuptake inhibitors.
New users of fluoxetine, the only antidepressant approved by the FDA for the treatment of depression in children and adolescents, increased by 60 percent. "However, there was no evidence of an increase in discontinuations of therapy with antidepressant or other psychotropic drugs, which suggests that the primary effect of the warnings was to alter the decision to treat a newly presenting patient," the authors write.
Previous studies have shown that the use of antidepressants among TennCare patients is similar to that of children and adolescents in the entire United States, suggesting that a similar decrease may have occurred in other populations.
Because there is so much uncertainly regarding the pediatric use of antidepressants, the implications of these changes are unclear, the authors note. "Thus, while it is now evident that regulatory interventions can alter patterns of practice, whether this is desirable is uncertain," they conclude. "There is an urgent need for better data on the efficacy and safety of antidepressants to guide pediatric practice."