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Impact of FDA black box warning may wane over time among depressed youth

Researchers found that the rate of antidepressant use among children from 2008 to 2011 returned to the rate seen before the FDA black box warning issued in 2004 regarding a possible link between antidepressants and suicidal ideation. The results, according to the researchers, raise concerns about the warning’s long-term impact.

“The trends in antidepressant use in the years immediately after the warning have been studied extensively; however, most studies since then have focused on retesting the effectiveness and risks of antidepressants for pediatric patients rather than analyzing the long-term effects of the black box warning on antidepressant use,” Nilay Kafali, PhD, from RTI International, and colleagues wrote in Psychiatric Services. “Analyzing the trends of antidepressant use among children is the first step toward understanding the long-run response of consumers, providers, and manufacturers to risk warnings.”

Researchers examined trends in antidepressant use among children aged 5 to 17 years with and without severe psychological impairment before and after the black box warning using 2000 to 2011 data from the Medical Expenditure Panel Survey (n = 75,819). They compared the changes in the rate of antidepressant use in the early (2004-2007) and late (2008-2011) years after the FDA warning with the rate in the years preceding the warning (2002-2003).

Analysis showed a 0.5% statistically significant reduction in antidepressant use among children in the early years after the warning compared with before the warning (P < .01). However, this immediate impact faded in the late years after the warning, as the prevalence of antidepressant use returned to the levels observed before the warning (2.29% in 2003 vs. 2.26% in 2009). Furthermore, the warning’s initial effect differed between children with severe and nonsevere psychological impairment, with a significant effect observed among those with nonsevere impairment.

“A return to the rates of antidepressant use before the black box warning raises concern that this thoughtful accounting of the risks and benefits may have dissipated over time,” Kafali and colleagues wrote. “An important policy implication of our findings could be that more frequent updates of FDA risk warnings might be necessary to prevent patients and the providers from ‘forgetting’ the potential risks outlined in the original warning.” – by Savannah Demko

Disclosure: The authors report no relevant financial disclosures.