Tuesday, November 17, 2015

More Children Were Prescribed Low-Dose Antidepressants After FDA Warnings, Study Finds

Following the Food and Drug Administration’s decision in 2004 to add a black-box warning to all antidepressants due to the increased risk of suicidal thinking or behavior among children, the proportion of youth who initiated a selective serotonin reuptake inhibitor (SSRI) at a low dose grew, according to a study published Monday in Psychiatric Services in Advance.

Although several studies have noted various effects of the 2004 black-box warnings—including changes in the use of antidepressants among youth and a shift in the care of these patients from generalists to psychiatrists—the warning’s effect on dosing was unknown.

In the current study, a team of researchers from the United States and the Netherlands examined data contained in the LifeLink Health Plan Claims Database on commercially insured children (aged 5 to 17), young adults (aged 18 to 24), and adults (aged 25 to 64) who initiated an SSRI (citalopram, fluoxetine, paroxetine, or sertraline) from January 1, 2000, to December 31, 2009. Dose per day was calculated on the basis of days’ supply, strength, and quantity dispensed; dose was defined by age group and SSRI agent on the basis of available guidelines and product labels, with low dose defined as less than the recommended initial dose.

Of the 51,948 children who initiated an SSRI between 2000 and 2009, 15% initiated with a low dose before the 2004 warning compared with 31% after the warning; there was a smaller change among young adults (6 percentage points) and adults (3 percentage points). The proportion of patients initiating an SSRI with a low dose after the 2004 black-box warning compared with before the warning was most prominent among children aged 13 to 17 (37% before versus 17% after), a relative increase of 116%.

“Given recent findings that the dose of the antidepressant may be associated with an increased risk of self-harm, as well as AACAP guidelines indicating that children and adolescents with depressive disorders should initiate antidepressant treatment with a low dose, our results suggest that prescribing practices surrounding SSRI dosing among children improved following the black-box warnings but still fall short of guidelines,” the study authors wrote.

For related information, see the Psychiatric News article “Experts Debate Effects of Antidepressant Warning.”

(Image: auremar/Shutterstock)


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