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As a psychiatrist specialized in perinatal and infant mental health, I have seen firsthand the devastating effects of untreated depression and anxiety in pregnancy—not only on the mother, but on her developing baby as well. Thus, I was deeply concerned to read about the recent US Food and Drug Administration panel discussion that suggested the idea of a black box warning on antidepressants during pregnancy.1
To be clear: no physician disputes the importance of carefully weighing risks when prescribing any medications in pregnancy. But these decisions must be based on science—not fear, stigma, or ideology. The science is indisputable: the risks of untreated maternal mental illness are real, measurable, and far more dangerous than the speculative concerns being used to justify black box warnings.
In the psychiatry world we’ve already witnessed what happens when regulatory actions overemphasize hypothetical risks of medication. In October 2004, after intense public, media, and political pressure, the FDA issued a black box warning for antidepressants in children and adolescents. This was based largely on reanalyses of unpublished industry trials suggesting that selective serotonin reuptake inhibitors (SSRIs) and other newer antidepressants could increase suicidal thoughts and behaviors—though not completed suicides—in youth. Shortly afterward, suicide rates among children and adolescents increased by 14%, the largest single-year jump in over 15 years.2 This history is a cautionary tale: well-intentioned warnings, when not paired with clear communication and medically nuanced guidance, can deter people from effective treatment—and, in some cases, cost lives. We cannot afford to repeat this mistake in the perinatal mental health space.
Women with untreated depression and anxiety during pregnancy are at higher risk of preterm birth, low birth weight, impaired bonding, postpartum depression. Most concerningly, they are at increased risk for suicide—the leading cause of maternal mortality in the United States.3 Not all women who experience perinatal mental health symptoms will need to take medication during pregnancy, and many with milder symptoms can thrive with therapy and behavioral interventions including nutrition, sleep, exercise, and social supports including paid parental leave. But for many, medications can be lifesaving, which is why these decisions should only be made after a thorough evaluation by a trusted physician—not by a panel advancing scientifically unsubstantiated claims. In my practice, I have cared for women who stopped their medications out of fear and spiraled into debilitating depression, putting themselves and their pregnancies in danger. These women are at risk for stopping their prenatal vitamins, relapsing with drugs or alcohol, or resorting to other unhealthy coping mechanisms. Furthermore, studies find that untreated depression and anxiety during pregnancy have real physiological consequences for both mother and child. Maternal mood disorders elevate circulating cortisol, which can cross the placenta and influence fetal HPA‑axis development, birth outcomes like preterm delivery, and even early brain structure and connectivity (eg, fetal heart-rate variability, amygdala volume)—with effects that may persist into childhood and beyond.4
By contrast, the absolute risk associated with SSRI use in pregnancy is small and has been studied for decades. Although some studies suggest a slight increase in risk for a transient and self-limited neonatal adaptation syndrome, these risks are low in absolute terms and often confounded by factors like socioeconomic status, comorbid conditions, and advanced maternal age.5 Given the ethical restraints in running randomized controlled trials on medications in pregnancy, it is often difficult to disentangle correlation from causation. For example, pregnant women with more severe illness are more likely to take medications during pregnancy. If this cohort has worse outcomes compared to unmedicated women, it can be challenging to determine whether the medication, the illness, or other factors are responsible. That being said, no study has shown SSRIs to cause consistent, major harm to the developing fetus. In fact, large population-based studies and expert consensus panels have concluded that SSRIs are generally safe in pregnancy, and when clinically indicated, often necessary.6
In my practice, I have seen time and again how prioritizing maternal mental health leads to better outcomes for mothers and their children. I have worked with many women who safely navigated pregnancy and postpartum while maintaining their psychiatric treatment—often a combination of therapy and medication. Their babies are healthy and their families are thriving. Their ability to parent effectively stems from their ability to stay well themselves and form healthy attachments with their children.
Unfortunately, due to scientifically unfounded fear-mongering, I fear that many women who greatly benefit from these medications—whose children benefit from their mothers’ stabilized mental health—will discontinue their medications during pregnancy. In a country already grappling with a maternal health crisis, this would be a catastrophic step backward.
What we need is not louder warnings, but better-informed consent and shared decision-making. Patients deserve nuanced, compassionate, and evidence-based discussions—not a black box warning that may cause panic or deepen shame. These conversations are already difficult in an especially vulnerable population; a black box warning would only add fear to an already stigmatized condition, making it harder for women to access the care they need.
As physicians, we must advocate for the whole patient—not just the baby, and not just the mother, but the dyad. A mother’s mental health is fetal health. When we support her, we protect them both.
Dr Simon is assistant professor of clinical psychiatry and assistant attending psychiatrist in child and adolescent psychiatry at Rutgers-Robert Wood Johnson Medical School.
References
1. FDA expert panel on selective serotonin reuptake inhibitors (SSRIs) and pregnancy. US Food and Drug Administration. July 21, 2025. Accessed August 13, 2025. https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-selective-serotonin-reuptake-inhibitors-ssris-and-pregnancy-07212025
2. Bridge JA, Greenhouse JB, Weldon AH. Suicide trends among youths aged 10 to 19 years in the United States, 1996–2005. American Journal of Psychiatry. 2008;165(9)L1158–1166.
3. Jahan N, Went TR, Sultan W, et al. Untreated depression during pregnancy and its effect on pregnancy outcomes: asystematic review. Cureus. 2021;13(8):e17251.
4. Wu Z, Meng Y, Ruan Z. Prenatal maternal psychological distress and fetal brain development: Evidence from structural and functional MRI. Mol Psych. 2024.
5. Hendson L, Shah V, Trkulja S. Selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors in pregnancy: infant and childhood outcomes. Paediatr Child Health. 2018;23(7):493-498.
6. Lebin LG, Novick AM. Selective serotonin reuptake inhibitors (SSRIs) in pregnancy: an updated review on risks to mother, fetus, and child. Curr Psychiatry Rep. 2022;24(11):687-695.