The US Food and Drug Administration's (FDA) black box warnings on antidepressants for children could be causing suicidal thoughts among youths since at least 2005, according to findings in recent research.
Black box warnings refer to a message inside a black border in the labeling or pamphlet of some medications, including antidepressants. These warnings are routine in product labeling and are designed to raise awareness of certain drug risks.
However, new research has found that the black box warning could help to worsen pediatric suicidality. Specifically, the warnings could lead to a reduction in mental health care and increase the number of psychotropic drug poisoning and deaths related to suicide among youths.
These findings were published Monday in the journal Health Affairs.
Effects on Youth
Black box warnings began appearing on medications in 2005. Since then, four of the 11 studies on which the findings are based found that doctor visits for depression (either symptoms or diagnoses) significantly declined after the warnings were implemented. Additionally, there were also abrupt declines in the use of antidepressants after the FDA introduced black box warnings. The declines were recorded to be between 20% to 50%.
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Additionally, three studies recorded an increase in psychotropic drug poisoning and suicide deaths among children after the warnings were introduced.
These effects were also found in young adults aged 18 to 24.
"We recommend that the FDA consider incorporating the Black-Box Warnings into the list of routine warnings that pose fewer health risks, or potentially removing the warnings altogether," the researchers said in their report.
What Do the Findings Mean
In response to the findings, Dr. Lisa R. Fortuna, chair of the Council on Children, Adolescents and Their Families at the American Psychiatric Association, told CNN via email that the findings should be considered. However, she noted that other factors could be affecting suicide rates in the US. This includes a lack of monitoring, concerns about prescribing antidepressants, and a lack of healthcare providers to see the youth who need care.
Fortuna was not involved in the research.
Moreover, the study focused on the short- and medium-term effects of warnings issued two decades ago.
