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Sagent Behavioral Health Mother Baby Program Comment on the FDA’s Panel on Antidepressants and Pregnancy

August 29, 2025

On July 21, 2025, the United States Food and Drug Administration convened a panel to discuss the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. The panel, unfortunately, biasedly focused on the risks of the medication and did not address the risks of mental health.

This letter aims to clarify the current evidence base regarding SSRI safety, the risks of untreated perinatal mental health conditions, and the clinical position of Sagent Behavioral Health Mother and Baby providers, which is consistent with the recommendations of the American Congress of Obstetricians and Gynecologists (ACOG) and world leaders in reproductive psychiatry. 

Safety of SSRIs During Pregnancy 

Recent meta-analyses and systematic reviews indicate that SSRIs, when prescribed during pregnancy, do not substantially increase the risk of major congenital malformations or neurodevelopmental disorders after adjusting for maternal psychiatric illness. The absolute risk of adverse outcomes such as preterm birth, persistent pulmonary hypertension of the newborn (PPHN), and poor neonatal adaptation is low, and these events are often transient or rare. For example, a 2018 meta-analysis of over 9 million births found only a slight increase in congenital malformations with SSRI exposure, which was not statistically significant when analyses were restricted to women with psychiatric diagnoses. The most consistently observed adverse effect is neonatal adaptation syndrome, occurring in 20–30% of exposed infants, typically resolving within days and without long-term neurodevelopmental consequences.  

Certain SSRIs, such as paroxetine and fluoxetine, have been associated with a small increased risk of cardiac malformations, but the absolute risk remains low and can be mitigated by avoiding these agents in favor of alternatives such as sertraline or escitalopram, which have more favorable safety profiles. The American Heart Association and ACOG recommend SSRIs as first-line pharmacotherapy for perinatal mood and anxiety disorders, emphasizing the use of the lowest effective dose and monotherapy when possible. 

Risks of Untreated Perinatal Mental Health Conditions 

Untreated perinatal depression and anxiety are associated with significant risks to both maternal and infant health, including poor obstetric outcomes, impaired maternal-infant bonding, and adverse neurodevelopmental effects in the child. Maternal psychiatric illness increases the risk of preterm delivery, low birth weight, and developmental delays, and is a major contributor to maternal morbidity and mortality. The literature consistently demonstrates that the risks of untreated maternal mental illness often outweigh the potential risks associated with SSRI exposure.  

Clinical Position of Sagent Behavioral Health Mother and Baby Providers 

Sagent Behavioral Health Mother and Baby providers endorse a patient-centered, evidence-based approach to the management of perinatal mood and anxiety disorders. In alignment with the American Academy of Obstetrics and Gynecology and the American Psychiatric Association, pharmacotherapy with SSRIs should not be withheld solely due to pregnancy or lactation status. The decision to initiate or continue SSRIs during pregnancy should be individualized, balancing the risks and benefits, and considering the severity of maternal illness, prior treatment response, and patient preferences. Psychotherapy remains the first-line intervention for mild to moderate depression, but SSRIs are appropriate for moderate to severe cases or when psychotherapy is insufficient or unavailable. 

To learn more about the Sagent Behavioral Health Mother Baby Program, click here. 

Samantha Huguelet DNP APRN  
Director of Sagent Behavioral Health Mother and Baby Program  

Dr. Zurya Anjum MD  
Sagent Behavioral Health Mother and Baby Program 

Kathryn Vele DNP APRN  
Sagent Behavioral Health Mother and Baby Program  

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