Youth suicide risk rose after FDA warned about antidepressants
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Key takeaways:
- Physicians reported no increase in monitoring of suicidal thoughts and behaviors after the warnings.
- Physician visits for depression decreased by one-third among adolescents.
FDA black box warnings about antidepressants for pediatric patients — meant to decrease suicidal thoughts and behavior — may have had the opposite effect, according to a systematic review.
The FDA issued an advisory in October 2003 warning of a possible association between antidepressants and suicidal thoughts and behaviors in children and adolescents aged younger than 18 years. The agency issued a black box warning in 2005 and expanded it to include young adults aged 24 years and younger in 2007.
“Although the FDA warnings were intended to increase monitoring of suicidal thoughts and behaviors at the start of antidepressant treatment, the warnings may have the unintended effect of frightening both physicians and youth,” Stephen Soumerai, ScD, professor of population medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute, and colleagues wrote.
Their systematic review included 11 studies published before Oct. 31, 2022, that measured outcomes following the initial advisory in 2003 or the subsequent black box warning in 2005. The findings were published in Health Affairs.
Soumerai told Healio that the warnings had a “chilling effect” on mental health care. Among 11 million adolescents, he said physician visits for depression diagnosis and treatment dropped by one-third.
“This increased suicide risks because doctors could not observe and evaluate teens’ severe depression, let alone treat it,” Soumerai told Healio.
After the FDA issued its warnings, psychotropic drug poisonings and suicide deaths rose among children and adolescents, according to the review.
The FDA said in its warnings that the goal was not to decrease antidepressant use, but to increase patient monitoring for suicidal thoughts and behavior, the researchers wrote. However, less than 5% of children and adolescents were monitored as the FDA recommended, according to the review.
“The FDA failed in its singular goal to increase monitoring of youth suicidal thoughts at the start of antidepressant treatment,” Soumerai told Healio. “Multi-year studies of pediatric patients found zero increase in such monitoring after the warnings, and the doctors themselves reported no increase in surveillance.”
The black box warnings are still in effect today, but Soumerai said the harms exceed the hypothetical benefits.
“Pediatricians and primary care physicians should heed this best evidence from the strongest studies and urge the FDA to demote these warnings to uncertain adverse effects or eliminate them altogether,” Soumerai said.
References:
- Soumerai SB, et al. Health Aff. 2024;doi:10.1377/hlthaff.2023.00263.
- Systematic review highlights decline in mental health care and increase in suicides following FDA youth antidepressant warnings. https://www.eurekalert.org/news-releases/1060134. Published Oct. 7, 2024. Accessed Oct. 7, 2024.
Perspective
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FDA warnings are intended to prevent harm, but this study indicates that they may not always achieve that goal. The initial warning regarding antidepressants aimed to enhance monitoring and reduce potential negative outcomes.
As clinicians, we must approach depression like any other illness. This includes prescribing medication, evaluating its effectiveness, addressing complications and incorporating psychotherapy, which is often overlooked but can be crucial. Treating severe depression requires an interdisciplinary approach, and although suicide is a risk, it should not be blamed solely on treatment; rather, it can stem from inadequate monitoring.
It's vital to recognize that although depression is the leading cause of suicide, numerous other factors contribute to this outcome. This is especially true for young people, whose psychosocial circumstances may be beyond their control, coupled with the fact that many are not screened for suicide risk. Without direct inquiries, prevention becomes nearly impossible.
The warnings have inadvertently instilled a fear of prescribing antidepressants among clinicians, rather than prompting improved monitoring practices. The focus should have been on implementing suicide screenings and safety planning, with regular follow-ups. However, I empathize with clinicians operating in a litigious environment.
Moreover, electronic health records may have exacerbated the issue by automatically populating refill options for up to a year, potentially overlooking necessary oversight.
While we frequently hear about FDA warnings regarding other medications, such as anti-epileptics, the conversation around antidepressants is much louder. This raises the question: is there a bias against mental health? It's a consideration worth exploring.
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