The U.S. Food and Drug Administration (FDA) has been cautioning about the potential link between antidepressants and suicidal thoughts in young people since 2003. These warnings were made more prominent in 2005 with the addition of a “black box” warning, first targeting minors and later expanded to young adults in 2007.
The purpose of this warning was to alert physicians and families about the risks, aiming to increase monitoring of suicidality in those taking antidepressants. However, a new systematic review of research suggests that these warnings may have had unintended negative consequences, potentially worsening mental health outcomes for youth.
The research, published in *Health Affairs*, found that the introduction of the black box warning led to reductions in both mental health care and antidepressant usage. Despite the FDA’s goal of improving safety and treatment monitoring, the study revealed that doctors were not consistently following recommended guidelines.
In fact, fewer than 5% of pediatric patients were monitored according to FDA guidelines for scheduled follow-ups, a rate no different from pre-warning periods. Moreover, there was a notable decline in both the number of visits for depression-related symptoms and in the prescription of antidepressants, which dropped by as much as 50% following the warnings.
These reductions in treatment coincided with an increase in suicidality and psychotropic drug poisonings, suggesting that fewer young people were receiving the care they needed. Four studies included in the review, which involved over 12 million patients, found significant declines in doctor visits and antidepressant prescriptions.
At the same time, three other studies reported increases in suicide deaths and drug poisonings among children, raising concerns that the warnings might have inadvertently contributed to these negative outcomes.
Dr. Stephen Soumerai, the lead author of the study and a professor at Harvard Pilgrim Health Care Institute, stated that the findings suggest the warnings may have had sweeping and unintended consequences.
The research showed consistent harm over 14 years, with no evidence of the intended benefits. Soumerai and his colleagues have suggested that the FDA might need to reconsider these warnings, potentially reducing their prominence or even removing them altogether if they are contributing to harm.
On the other hand, experts like Dr. Lisa Fortuna from the American Psychiatric Association have cautioned against drawing definitive conclusions. She noted that while the black box warnings intended to increase monitoring, the study found that these guidelines were largely ignored.
Fortuna explained that many providers and families may have grown hesitant to prescribe antidepressants due to fears of the potential risks, leading to untreated depression and worsening suicidality. However, she also highlighted that the broader mental health crisis, exacerbated by the pandemic, likely plays a significant role in the rising suicide rates, making it difficult to directly link the warnings to these outcomes.
In conclusion, while the study provides important insights into the potential downsides of the black box warnings, experts stress the need for a nuanced approach. The decision to use antidepressants should involve careful assessment, considering the potential risks and benefits.
Despite concerns raised by the findings, antidepressants remain an essential tool in treating depression when monitored closely. Open communication between clinicians, families, and patients is vital to ensure that depression is addressed effectively, and that all treatment options are thoroughly considered.
