FDA weighs risks of antidepressants in pregnancy as acetaminophen concerns also mount
- An FDA panel debated adding “black box” warnings to antidepressants like SSRIs, citing potential fetal risks.
- Studies link SSRIs to neonatal complications but emphasize risks of untreated maternal depression as more dangerous.
- Over 65% of pregnant women take acetaminophen; emerging evidence suggests it raises neurodevelopmental risks.
- Maternal mental health is now the leading cause of pregnancy-related deaths in the U.S.
- Maternal outcomes are better in all areas with the midwifery standard of care.
In July 2025, the Food and Drug Administration convened a panel to examine antidepressant safety during pregnancy, sparking a fiery debate over balancing maternal mental health needs against perceived risks. The discussion, influenced by critics of psychiatric medication, centered on selective serotonin reuptake inhibitors (SSRIs), such as Prozac and Zoloft, which over 5% of North American pregnant women use.
Panelists like Dr. Adam Urato, a maternal-fetal medicine specialist, argued for stronger warnings, emphasizing potential heart defects, neurodevelopmental delays and developmental disorders linked to SSRIs. “We’re chemically altering developing babies without adequate public warning,” he told the FDA.
This shift reflects broader priorities under Health and Human Services Secretary Robert F. Kennedy Jr., who has advocated reducing psychotropic prescriptions. However, critics, including Dr. Nancy Byatt of UMass Chan Medical School, warn that sidelining medication could harm pregnant women, as though pharmaceuticals are the only option. “Untreated depression is life-threatening,” she said. “This panel ignored that reality.”
Risks of medication vs. untreated mental illness
Decades of research highlight the delicate equation: SSRIs are linked to rare neonatal issues like jitteriness and transient muscle tone problems, but evidence for lasting harm to offspring is weak. More concerning is untreated maternal mental health, which the CDC ranks as the leading cause of pregnancy-related death, accounting for 8% of fatalities.
Untreated depression elevates risks of preterm birth, preeclampsia and postpartum suicide. A 2022 CDC report found that mental health conditions, including substance use and suicide, contribute to 23% of preventable maternal deaths.
So, why not a third option?
Critics say the FDA panel overlooked the dangers of poor maternal mental health, but that was not their purpose. They were looking to see if there is danger from the medication, with the next step being to determine what to do about it. “They focused only on medication risks while dismissing the catastrophic mental health consequences of stopping SSRIs,” said psychologist Andrew Novick, co-author of an opinion piece in Live Science. However, counseling and diet/nutrition have consistently shown better results in treating depression across the board, and pose no risk to the baby.
Acetaminophen’s rising concerns: A silent epidemic in maternal care
While SSRIs dominate debates, over-the-counter medications like acetaminophen—used by 65% of U.S. pregnant women—are increasingly scrutinized for risks as well. A Nature Reviews Endocrinology consensus statement (September 2025) linked prenatal exposure to endocrine disruption, neurodevelopmental disorders like ADHD, and reproductive abnormalities.
Animal studies suggest acetaminophen impairs testosterone, critical for fetal brain growth, while human data ties it to delayed language development and autism in children. “This drug is ubiquitous and perceived as safe, but the evidence is alarming,” warned professor Shanna Swan of Mount Sinai.
Yet regulatory action lags. With opioids and NSAIDs contraindicated late in pregnancy, acetaminophen remains a default for pain. “Women need alternatives, not just sharper warnings,” said Dr. Xiaobin Wang of Johns Hopkins.
MAHA movement’s focus on child health puts maternal pharmaceutical use under scrutiny
With maternal mortality rates soaring to 700+ annual deaths in the U.S.—triple that of comparable nations—the current FDA panel’s recommendations could exacerbate preventable tragedies if women are not offered alternatives. Mental health conditions and substance use now underpin nearly a quarter of these deaths, many tied to unaddressed depression or stigma around treatment. Americans have more chemicals in every aspect of their lives than most other developed nations: food, water, personal products, in addition to only pharmaceuticals being offered by Western medicine as solutions to common problems.
Historically, maternal care has marginalized women’s voices. Dr. David Healy, a panelist criticizing SSRIs, acknowledged this pattern: “For years, depression was dismissed as ‘womanly woes.’” The 2004 warning exemplifies the risks of reactive policy: reduced antidepressant use correlated with increased maternal suicide rates.
Today, anti-opioid sentiment and a culture stigmatizing medication are pushing women to seek out natural health alternatives, and there is more demand than supply. Use of midwives at hospitals and birth centers has increased steadily over the last two decades, as have home births, while maternal mortality has decreased (globally) during the same time. The incorporation of midwifery as the standard for maternal care consistently improves outcomes for mothers and babies. Hallmarks of midwifery care include emotional counseling as well as nutritional counseling. Midwives treat the whole woman; they do not just check the baby’s vitals. (The average obstetrician appointment lasts for 7 minutes [15 total, 7 with the doctor]; the average midwife appointment is 1 hour.)
Embracing holistic maternal care for safer futures
The escalating concerns over medications like acetaminophen and SSRIs highlight the urgent need to reevaluate our reliance on pharmaceuticals in maternal care. While these drugs may address immediate symptoms, their potential risks to fetal development and maternal health underscore the critical gap in natural, non-pharmacological alternatives. Instead of racing toward stricter warnings, we must prioritize expanding access to evidence-based, holistic care models like midwifery, which center maternal well-being through empathy, education and prevention.
Midwives offer a transformative alternative, providing comprehensive support that addresses both physical and mental health without defaulting to risky medications. Their model of care—rooted in nutritional counseling, emotional guidance and patient autonomy—has been proven to reduce cesarean rates, improve breastfeeding success, and yield higher maternal satisfaction. Importantly, midwives’ integration into healthcare systems correlates with fewer disparities in maternal outcomes, particularly for Black and Indigenous communities, who face disproportionately high mortality rates due to systemic neglect. Research shows midwives could avert nearly 40% of maternal deaths globally, yet systemic barriers—such as restrictive regulations and insufficient federal funding—stifle their role in U.S. care delivery.
Women and babies deserve more, better options
The FDA’s current scrutiny of antidepressants and acetaminophen must serve as a catalyst for broader systemic change—not just drug regulation, but an expansion of midwifery-led care. This approach reduces the need for pharmaceuticals while empowering pregnant women through education on nutrition, stress management and natural pain relief. As untreated mental health crises and fetal risks highlight the failures of current protocols, policymakers must dismantle legislative hurdles and invest in midwifery training and reimbursements. To truly protect mothers and babies, we must prioritize care that values the whole person, not just symptom suppression.
By destigmatizing midwifery and ensuring equitable access, we can chart a path toward maternal health that honors evidence, safeguards development and guarantees dignity. The stakes are undeniable: safer pregnancies, healthier families and a future where every mother has the tools to thrive without relying on drugs whose costs may outweigh their benefits. Women have been caring for women during pregnancy and birth since the dawn of humanity. Let this moment be a call to dismantle barriers, return to the natural order and reimagine care—one that respects the profound connection between maternal well-being and the environments we create for our children.
Sources for this article include:
LiveScience.com
NYTimes.com
STATnews.com
TheConversation.com
CommonwealthFund.org
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