The balancing act between treating depression and safeguarding fetal development has never been more visible than in the recent deliberations held by the US Food and Drug Administration (FDA). With selective serotonin reuptake inhibitors (SSRIs) among the most commonly prescribed medications for depression and anxiety, understanding their implications during pregnancy is critical for patients, clinicians, and policymakers alike. The latest FDA expert panel, convened in July 2025, brought together leading voices in psychiatry, obstetrics, developmental biology, and epidemiology to grapple with the evidence, misconceptions, and real-life consequences of SSRI use in pregnant women.
Background: Why SSRIs and Pregnancy Are Under the Microscope
SSRIs—including fluoxetine (Prozac), sertraline (Zoloft), citalopram (Celexa), and others—are often considered first-line treatments for depression and anxiety. According to FDA Commissioner Marty Makary, “nearly 1 in 4 middle-aged women are on an antidepressant, and up to 5% of women in pregnancy are on an antidepressant.” These numbers highlight both the prevalence of mental health concerns and the ubiquity of pharmacologic solutions in the United States.
Yet, despite this widespread use, the FDA acknowledges that “the broader picture of mental health in the United States has not improved despite increasing prescriptions.” The paradox is clear: more antidepressants, but not necessarily less depression. This reality sets the stage for the urgent inquiry—do the benefits of SSRIs during pregnancy outweigh the risks, or are we underestimating potential harms to mothers and their babies?
Scientific and Clinical Evidence: What the Data Tell Us
SSRIs are effective for many people in alleviating symptoms of depression and anxiety. However, pregnancy introduces additional biological complexity. SSRIs cross the placenta, meaning that developing fetuses are exposed to these drugs, which in turn can influence brain and organ development.
Dr. Anick Bérard, professor of Perinatal Epidemiology at the University of Montreal, emphasized, “Untreated depression and anxiety during pregnancy has been shown to be associated with an increased risk of postpartum depression.” She further clarified that while some studies suggest a relative elevation in risks—such as for miscarriage or autism—the absolute risk remains low. These findings must be interpreted with nuance, as the baseline risk for many adverse outcomes is already small.
On the other hand, Dr. Jay Gingrich, director of the Institute for Developmental Sciences at Columbia University, highlighted new research linking prenatal SSRI exposure to increased rates of adolescent depression. “Until recently, there’s really never been any attempt to study whether this treatment of the mother actually improves outcomes in the offspring,” he noted. Gingrich and others stress that serotonin, the neurotransmitter targeted by SSRIs, plays vital roles in fetal development distinct from its functions in adults—acting as a neuromodulator for organ and neural formation.
Dr. Adam Urato, chief of Maternal-Fetal Medicine at MetroWest Medical Center, argued for stronger FDA warnings. He pointed to both animal and human imaging studies indicating that “SSRIs alter fetal brain development” and warned that these medications can be difficult to discontinue, underscoring the need for preconception counseling.
Conversely, Dr. Kay Roussos-Ross, director of the Perinatal Mood Disorders Program at the University of Florida, defended the necessity of treatment. She stated, “One in 5 women will have a perinatal mood disorder. Psychotherapy and SSRIs are tools that we have… Treating mental illness in pregnancy is not a luxury. It’s a necessity.” She cited evidence that untreated maternal depression can lead to adverse outcomes, including preterm birth, poor prenatal care, and even maternal suicide.
Case Vignette: Sarah’s Story
Sarah, a 32-year-old marketing professional, has struggled with major depressive disorder for much of her adult life. When she and her partner decided to start a family, Sarah consulted her psychiatrist. She had been stable on sertraline for over a year, but now faced a difficult decision: continue her medication and risk potential harm to her baby, or discontinue and risk a relapse into debilitating depression. Her psychiatrist explained both the known risks (such as a slightly increased risk of neonatal adaptation syndrome and, very rarely, cardiac defects) and the risks of untreated depression (missed prenatal appointments, poor nutrition, increased risk of substance use, and suicide). Sarah ultimately decided to continue her medication, supported by frequent therapy sessions and close monitoring by her obstetrician.
Misconceptions and Harmful Behaviors
One of the most pervasive misconceptions is that antidepressants “correct a chemical imbalance.” Dr. Joanna Moncrieff, professor of Critical and Social Psychiatry at University College London, asserts, “There is very little evidence that antidepressants have actual benefits in depression.” She and others argue that improvements may result from non-specific psychoactive effects, not the correction of a biochemical defect.
Dr. Jeffrey Lacasse, associate professor at Florida State University, highlighted that “88% of Americans believe that antidepressants correct chemical imbalances, despite no conclusive scientific basis.” This belief, he argued, contributes to overprescribing among women of reproductive age. The risk here is twofold: women may remain on medications they don’t need, and some may discontinue necessary treatment abruptly out of fear, risking withdrawal or relapse.
The Role of Serotonin in Fetal Development
Dr. Michael Levin, a developmental biologist at Tufts University, provided critical insights into the role of serotonin in early embryonic patterning. His laboratory’s research in frogs and chicks demonstrates that “manipulating [serotonin’s] use by cells with SSRIs is very, very likely to cause certain kinds of defects,” including organ asymmetry. While animal models do not always translate to human outcomes, these findings raise important questions about how SSRIs might impact development in ways not yet fully understood.
SSRI-Associated Risks: What Do We Know?
The table below summarizes key findings from recent literature reviews and meta-analyses:
| Adverse Outcome | Relative Risk | Absolute Risk | Comments |
|---|---|---|---|
| Preterm Birth | 1.2–1.5x | From ~6% to 7–9% | Confounded by maternal illness |
| Neonatal Adaptation Syndrome | 2–4x | ~20–30% | Usually mild, resolves in days |
| Persistent Pulmonary Hypertension | ~2x | From 1–2 per 1000 to 2–4 per 1000 | Very rare |
| Autism Spectrum Disorder | 1.2–1.8x | From 1% to ~1.2–1.8% | Absolute increase is small |
| Congenital Heart Defects | ~1.2–1.5x | ~1% to 1.2–1.5% | Some SSRIs higher risk (paroxetine) |
Sources: Huybrechts KF et al., N Engl J Med 2014; Grigoriadis S et al., JAMA 2014; Brown HK et al., JAMA 2017.
Correct Health Practices and Practical Recommendations
Guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the American Psychiatric Association (APA) recommend individualized risk-benefit analysis for women considering SSRIs during pregnancy. Key points include:
- For women with severe, recurrent depression, maintenance of antidepressant therapy may be warranted.
- Preconception counseling is vital—discuss risks, benefits, and alternative therapies before pregnancy.
- Nonpharmacologic interventions (such as cognitive behavioral therapy or interpersonal therapy) should be considered, especially for mild to moderate depression.
- When SSRIs are used, select agents with the best safety profile (e.g., avoid paroxetine due to higher risk of cardiac defects).
- Monitor closely for neonatal adaptation syndrome and other complications after delivery.
Expert Insights and Regulatory Perspectives
At the FDA panel, Dr. Josef Witt-Doerring, a psychiatrist and former FDA medical officer, criticized inconsistent labeling of SSRI risks. He suggested that “QR codes on prescription bottles linking to FDA-approved risk summaries” could empower patients with better information. Many panelists agreed that transparency and improved patient education are sorely needed.
Dr. Urato concluded, “Never before in human history have we chemically altered developing babies like this… without any real public warning.” The panel did not reach a consensus on new regulatory actions but urged the FDA to consider enhanced labeling, more accessible educational materials, and expanded access to nonpharmacologic treatments.
Conclusion
The FDA’s recent panel on SSRIs and pregnancy underscores the complexity and urgency of this issue. While SSRIs can be life-saving for some women, their use in pregnancy must be carefully weighed against potential risks to both mother and child. The path forward is not about a one-size-fits-all answer, but about transparent, evidence-based conversations—between patients and their care teams, and within the wider medical community. As research continues to evolve, so must our approach to managing depression and anxiety in pregnancy, combining empathy, science, and informed choice.
References
1. Huybrechts KF, et al. Antidepressant Use in Pregnancy and the Risk of Cardiac Defects. N Engl J Med. 2014;370:2397-2407.
2. Grigoriadis S, et al. Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysis. JAMA. 2014;311(6):594–606.
3. Brown HK, et al. Association Between Antidepressant Use During Pregnancy and Autism Spectrum Disorder in Children. JAMA. 2017;317(15):1544–1552.
4. FDA. FDA Expert Panel on Selective Serotonin Reuptake Inhibitors (SSRIs) and Pregnancy. FDA July 21, 2025. Accessed July 21, 2025. https://www.youtube.com/watch?v=2Nha1Zh63SA
5. American College of Obstetricians and Gynecologists. Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2018;132:e208–e224.
6. Yonkers KA, et al. Management of depression during pregnancy. Obstet Gynecol. 2009;114(5):1181–1188.
