Study finds more children were prescribed low-dose antidepressants after FDA issued warning

December 1, 2015

A recent study co-led by researchers from the UNC Gillings School of Global Public Health found that after the Food and Drug Administration (FDA) added a black-box warning to all antidepressants in 2004, more young people initiated treatment on low doses of selective serotonin reuptake inhibitors (SSRIs).

Greta Bushnell

Greta Bushnell

Co-authors from the Gillings School are Greta A. Bushnell, MSPH, doctoral student, Til Stürmer, MD, PhD, professor, Alice White, PhD, adjunct associate professor, and Virginia Pate, MS, applications analyst, all with the Department of Epidemiology.

The study, titled “Dosing of Selective Serotonin Reuptake Inhibitors Among Children and Adults Before and After the FDA Black-Box Warning,” was published online Nov. 17 by Psychiatric Services in Advances.

The 2004 black-box warning linked antidepressant use with an increased risk of suicidal ideation and behavior among youth and came with a recommendation for close patient monitoring after antidepressant initiation.

Prior research has evaluated various effects of the black-box warning among youth — including changes in the use of antidepressants in this population and a shift in the care of patients from generalists to psychiatrists — but this study marks the first examination of the warning’s effect on antidepressant dosing.

The research team utilized the LifeLink Health Plan Claims Database to analyze effects among commercially insured children (ages five to 17), young adults (18 to 24) and adults (25 to 64) who initiated an SSRI between Jan. 1, 2000 and Dec. 31, 2009.

Of 51,948 children in the cohort who initiated an SSRI during the time frame of the study, 15 percent initiated with a low dose before the 2004 warning compared with 31 percent after the warning. The change was most prominent among children aged 13 to 17. There was a smaller shift toward low-dose options among young adults (six percentage points) and adults (three percentage points).

“Even though the FDA warning came with no recommendation regarding antidepressant dosing, we observed more children initiating on a low dose after the warnings,” Bushnell explains. “Perhaps this is an indication that providers began to exert more caution in terms of the initial SSRI dose prescribed.”

As the proportion of commercially insured children initiating an SSRI with a low dose was higher after the 2004 FDA warning, and as prescribing guidelines now recommend children initiate SSRIs with low doses followed by gradual increases in dose as needed, the researchers concluded that the warning was associated with improved prescribing practices related to SSRI dosing among youth.

Gillings School of Global Public Health contact: David Pesci, director of communications, (919) 962-2600 or