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NCRP Responds to FDA Panel on SSRI Use in Pregnancy

September 5, 2025

The National Curriculum in Reproductive Psychiatry (NCRP) is issuing this response following the recent FDA panel discussion on the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy. While we appreciate the agency’s attention to maternal mental health, we are deeply concerned that the panel included speakers who presented misleading or stigmatizing information about psychiatric treatment during pregnancy, undermined the scientific consensus, and failed to appropriately center the well-being of pregnant individuals.

Misrepresentation and Ideological Bias

Several panelists presented outdated or ideologically driven critiques of antidepressants rather than focusing on the panel’s intended topic: reproductive safety of SSRIs. When the context of pregnancy was discussed, claims of widespread harm were often based on studies that failed to adequately control for confounding by indication-that is, the underlying mental health condition for which the medication was prescribed. As Dr. Kay Roussos-Ross emphasized multiple times during the panel, more recent and methodologically rigorous studies that control for the presence and severity of depression have confirmed that earlier findings of harm no longer hold up when appropriate control groups are used. This reflects a central limitation of the existing literature: conflating the effects of medication exposure with the effects of untreated or undertreated psychiatric illness. While a few risks attributable to the use of SSRIs in pregnancy remain, the bulk of the evidence confirms that the risks of untreated illness generally outweigh the risks of medication use for those with moderate to severe depression.

In contrast, the panel repeatedly cited findings of associations-such as congenital malformations or autism spectrum disorder- without clearly acknowledging the limitations of the studies behind these findings. Current data do not support a causal relationship between prenatal SSRI exposure and either congenital malformations or ASD. While SSRIs do influence serotonin pathways involved in early fetal development, biological activity is not the same as pathology. Many essential medications affect fetal physiology-what matters is whether that effect causes harm, and current data do not show that SSRIs cause sustained differences in developmental trajectories. Dr. Jay Gingrich clearly articulated this nuance during the discussion. He acknowledged that while SSRIs have theoretical effects on neurodevelopment, the evidence in humans has not demonstrated adverse outcomes in children exposed in utero. This remark reflected the kind of scientific humility and balanced interpretation that should guide these discussions.

Unfortunately, other panelists relied on sensationalism and false equivalence. For example,

  • Dr. David Healy claimed SSRIs cause alcohol use disorder and suggested that if a medication causes birth defects, it implies that it also causes autism-none of which is supported by scientific consensus.
  • Additionally, he advocated using individual cases to make sweeping judgments about medication safety, which is the antithesis of public health science.
  • Dr. Jeffrey Lacasse invoked the outdated “chemical imbalance” theory to discredit SSRI use-a simplification irrelevant to current clinical rationale or safety in pregnancy.
  • Dr. Roger McFillin dismissed the value of scientific communication, stating that the public “doesn’t want graphs” and instead wants a to hear information from the heart-a deeply patronizing and dangerous claim that undermines the public’s right to clear, evidence-based information.
  • He also implied that women’s higher rates of depression reflect a “gift” of emotional sensitivity-a biologically uninformed view that disregards decades of research on reproductive hormonal transitions and their impact on mood. It also ignores the fact that reproductive hormones are neuroactive steroids with direct binding sites in the brain, influencing emotional regulation and stress response across the menstrual cycle, pregnancy, postpartum, and menopause.

False Dichotomies

Multiple panelists framed care as a binary: SSRIs vs. lifestyle interventions. This is a false dichotomy. Clinical guidelines recommend SSRIs only when indicated and alongside additional evidence-based treatments and strategies like psychotherapy, physical activity, restful and adequate sleep, and social connection.

The Other Side of Risk: Untreated Mental Illness

Apart from the testimony provided by Dr. Kay Roussos-Ross, the panel largely failed to address the serious risks of untreated antepartum mood and anxiety disorders, which include:

  • Preterm birth and low birth weight
  • Poor prenatal care engagement and increased substance use
  • Increased risk of postpartum depression (untreated antenatal depression is the strongest risk factor for PPD)
  • Impaired maternal-infant bonding and attachment
  • Behavioral and emotional concerns in offspring
  • Suicide-a leading cause of maternal mortality in the U.S.

For a pregnant individual experiencing a major depressive episode or anxiety disorder, treatment decisions necessarily involve navigating risk. Discontinuation of mental health treatment during pregnancy, often due to fear or stigma, is a known factor in maternal suicides, as documented by multiple maternal mortality review committees. Public messaging that exaggerates the risks of SSRIs while minimizing or ignoring the risks of untreated illness is not only misleading–it is dangerous.

Reaffirming the Evidence-Based Role of SSRIs During Pregnancy

While data informing SSRI use in pregnancy are limited to retrospective, observational studies, these medications are among the most extensively studied in this population. When clinically indicated for moderate to severe depression or anxiety, SSRIs are recommended by the American College of Obstetricians and Gynecologists (ACOG), the American Psychiatric Association (APA), and the Society for Maternal-Fetal Medicine (SMFM).

These medications are just one part of comprehensive, evidence-based mental health care. For many individuals- particularly those without access to psychotherapy-SSRIs may be the most effective and readily available option. Stigmatizing their use endangers patients and undermines providers.

A Call for Inclusion in Research

We acknowledge that observational studies have limits. The persistent exclusion of pregnant people from randomized controlled trials (RCTs) has left critical gaps in evidence. We urge the FDA and research institutions to invest in ethical, well-designed RCTs that include pregnant participants, so future decisions are grounded in science- not ideology.

A Note of Appreciation for Scientific Integrity

We are especially grateful to Dr. Kay Roussos-Ross for her clarity and clinical insight. As a physician trained in obstetrics and gynecology, psychiatry, and addiction medicine, she brought a uniquely informed perspective rooted in real-world care. She reminded the panel that SSRIs are not risk-free, but when used appropriately, they are low risk and often lifesaving. Her participation underscored the importance of reproductive psychiatry as a field, highlighting the need for experts who can translate evolving research into patient-centered, clinically grounded care.

About NCRP

The National Curriculum in Reproductive Psychiatry (NCRP) is dedicated to advancing the education of healthcare professionals in the assessment and treatment of psychiatric conditions during reproductive life events. Through standardized training and evidence-based resources, we aim to ensure that every person receives the mental health care they deserve before, during, and after pregnancy. Contact us at reprotaskforce@gmail.com.

Correction Notice (Updated 7/22/2025)

An earlier version of this statement misattributed two comments to Dr. Jeffrey Lacasse that were, in fact, made by Dr. Roger McFillin during the FDA panel discussion. These comments included the assertion that the public doesn’t want graphs and the characterization of women’s higher rates of depression and anxiety as a form of emotional sensitivity or gift. We regret the error and have corrected the attribution in the revised version of the statement.

Dr. Lacasse did invoke the outdated “chemical imbalance” theory to discredit SSRI use, which remains accurately described and appropriately cited.

We are committed to maintaining the highest standards of accuracy and transparency in our communications and thank those who brought this to our attention.

- NCRP

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