Warnings Of Youth Suicidal Behaviors From The FDA Were Followed By Increased Deaths By Suicide

Boston, 3 Nov 2020: 

Deaths by suicide have increased among the young following advisories by the Food and Drug Administration (FDA). These findings, from an interrupted time series study, were published in Psychiatric Research and Clinical Practice.

Researchers from the Harvard Medical School obtained data on suicide deaths from the Centers for Disease Control and Prevention WONDER database. These data included mortality counts from death certificates from 1990 to 2017 for individuals residing in the United States. Data for adolescents (aged 10 to 19 years) and young adults (aged 20 to 24 years) were analyzed for this study.

These data were correlated with an advisory from the FDA in 2003 which stated adolescents were at increased risk for suicidal ideation and behavior when taking antidepressants. In 2005, warnings were incorporated with drug labeling. Time periods were defined as pre-warning (1990-2002), transition (2003-2004), and post-warning (2005-2017).

Among adolescents, deaths by suicide were declining at the start of this study period, from 6.4 per 100,000 in 1990 to 4.2 in 2002 (-0.18 deaths per 100,000 deaths per year; 95% CI, -0.21 to -0.15; P <.001). After the transition phase, a moderate increase in suicide deaths per 100,000 adolescents was observed (4.4 in 2005), which increased to 7.2 in 2017.

During the post-warning, an immediate increase of 0.49 deaths per 100,000 (95% CI, 0.12-0.86) was observed with a sustained trend of 0.03 additional suicide deaths per 100,000 per year (95% CI, 0.026-0.031). The difference between pre- and post-warning trends suggested that the warning resulted in an excess 2365 deaths by suicide among adolescents between 2005 and 2010 (total population 43 million).

Among young adults, deaths by suicide were also declining in 1990, from 15.1 per 100,000 deaths to 12.3 in 2002 (-0.36 deaths per 100,000 per year; 95% CI, -0.34 to -0.28; P <.001). After the transition phase, the suicide rate was 12.5 per 100,000 in 2005, which increased to 17.0 in 2017.

The immediate increase of suicides after the warning was 2.07 deaths per 100,000 (95% CI, 1.04-3.10) with a trend of 0.05 suicide deaths per 100,000 per year (95% CI, 0.04-0.06). The discrepancy between the pre- and post-warning suicide rates was equivalent to 3593 additional suicide deaths between 2005 to 2010 among young adults (total population 21 million).

During the total study period, the rates of death due to unintentional injury declined. This trend was not affected by the FDA warnings.

This study was potentially limited by not incorporating data on possible cofactors for stressors including information on financial insecurity from the most recent recession, impacts from the opioid epidemic, or the rise in social media use which may have increased anxiety or introduced cyberbullying.

The study authors concluded that after warnings for suicidal ideation or behaviors were included on antidepressant packaging, suicide deaths have increased likely due to the unintentional side effect that fewer young adults and adolescents sought care for their depression symptoms. These data indicated a reevaluation of FDA packaging warnings are needed.

Reference

Lu CY, Penfold RB, Wallace J, Lupton C, Libby AM, Soumerai SB. Increases in suicide deaths among adolescents and young adults following US food and drug administration antidepressant boxed warnings and declines in depression care. [published online October 7, 2020] Psych Res Clin Pract. doi:10.1176/appi.prcp.20200012. Psychiatry Advisor