Did the FDA Mislead Pregnant Women About Antidepressant Risks? Psychiatrists Speak Out

The use of antidepressants during pregnancy is a deeply contentious and complex issue at the crossroads of maternal mental health and fetal safety. Recently, attention has turned to whether the U.S. Food and Drug Administration (FDA) may have inadvertently—or deliberately—misled pregnant women about the risks of these medications. A July 21, 2025 FDA convocation of external experts elevated concerns about selective serotonin reuptake inhibitors (SSRIs) during pregnancy, with some speakers accusing the agency of softening or downplaying the drugs’ dangers. The history of the FDA’s guidance, current expert opinions, and the voices of psychiatrists on both sides of the debate.

Background: FDA’s Role & Historical Warnings

From Letter Categories to PLLR

Until 2015, FDA pregnancy categories (A, B, C, D, X) offered cursory guidance—with SSRIs often labeled Category C (“Risk cannot be ruled out”)—leading to both misinterpretations of safety and undue alarm. Following criticism, the FDA replaced this system with the Pregnancy and Lactation Labeling Rule (PLLR): a more descriptive, narrative approach intended to offer context, recent data, and balanced risk/benefit profiles.

2005–06 Safety Alerts

Notable high-profile FDA advisories include:

• 2005: A “negative” buzz about paroxetine (Paxil) and congenital cardiac defects.
• 2006: Warnings about SSRI-associated persistent pulmonary hypertension of the newborn (PPHN)—based partly on a single small study indicating a sixfold increased risk.

Notably, even then the FDA cautioned that women should not stop SSRIs during pregnancy without medical advice, citing relapse risk.

The Evolving Evidence Base

Early Birth Defects & Congenital Anomalies

The strongest evidence linking SSRIs to specific birth defects (particularly paroxetine with heart defects) emerged from observational studies—but limited by methodology and confounding. More recent large-scale registries indicate that when controlling for maternal depression and health behaviors, most SSRIs—including fluoxetine, sertraline, citalopram—show little to no significant increase in congenital abnormalities.

PPHN and Neonatal Adaptation Syndrome

While initial reports noted a substantial PPHN risk increase, follow-up studies—such as Huybrechts et al (2015)—showed that when maternal confounders are accounted for, the risk diminishes considerably. Meanwhile, neonatal adaptation syndrome (irritability, tremors, respiratory symptoms) remains documented but generally transient and manageable.

Neurodevelopmental Impacts

Concerns have persisted about subtle effects on cognitive, behavioral, or social development—including autism spectrum links. However, studies reveal either weak or inconsistent associations, often confounded by familial factors such as maternal depression or genetics.

Panel on July 21, 2025: Key Testimony

A high‑profile FDA panel convened on July 21, 2025, to reassess SSRI levels of warning.

• Chair Martin Makary noted SSRIs can pose risks and urged a more critical stance on prescription practices.
• Joanna Moncrieff (UCL) claimed there is “very little evidence that antidepressants have actual benefits in depression,” calling into question the efficacy rationale for pregnancy use.
• Adam Urato, MFM expert, urged for “better risk information” citing links to pregnancy complications.
• Josef Witt‑Doerring called for better informed consent, including rigorous warnings, and raised concerns about SSRI withdrawal risks.
• Kay Roussos‑Ross opposed harsh warnings, emphasizing untreated depression’s risks (relapse, postpartum depression) and called for patient‑centered balance.

No formal policy changes were announced, but the variety of expert views revealed mounting pressure on the FDA to enhance labeling.

Did the FDA Mislead?

Arguments For “Yes”

Critics argue:

1. Overreliance on Old Letter Categories: The simplicity of categories C/D may have instilled a false sense of safety.
2. Delay in PLLR Implementation: Extended transition periods may have left doctors and patients with outdated guidance.
3. Minimal Context on Labels: Even under PLLR, some clinicians feel current SSRI labeling understates subtle risks.
4. FDA Messaging: Public communications often emphasize depression treatment benefits more than fetal risks.

The FDA’s prior public statements—endorsing consulting providers before discontinuing SSRIs—were criticized for signaling reassurance without matching clarifications on evolving safety data.

The Citizens Commission on Human Rights, an advocacy group, has urged the FDA to revise guidance, citing studies of lower birth weight, increased preterm birth, PPHN, neonatal hospitalization, and withdrawal in over 45,000 births.

Arguments For “No, But Insufficient Clarity”

Supporters of FDA policy say:

1. FDA is Data-Driven & Transparent: The agency has actively issued updates in 2005 and 2006.
2. Shift to PLLR Framework: Narratives now include nuanced risks and benefit contexts.
3. Strong Emphasis on Maternal Mental Health: Depression itself can pose serious risks—untreated illness may cause poor prenatal care, substance use, preterm birth, and postpartum complications.
4. Ongoing Research Encouragement: The FDA promotes enrollment in pregnancy exposure registries and continues to update labels as data evolve.

From this angle, any perceived “misleading” oversimplification reflects the inherent ambiguity of emerging data, not bad faith.

Input from Psychiatrists & Experts

Pro-warnings advocates believe women deserve more caution:

• Adam Urato has repeatedly emphasized risk evidence—urging medications to be used “with much caution” in expectant mothers.
• From advocacy organizations like CCHR: “Prescribers have an obligation to fully disclose … discuss evidence‑based, non‑drug alternatives”.

Balanced-care advocates emphasize comprehensive, individualized treatment:

• Dr. Catherine Birndorf of The Motherhood Center stresses treating antenatal depression promptly—supporting medication plus psychotherapy—warns that untreated depression often leads to postpartum relapse and maternal suffering.
• Kay Roussos‑Ross frames SSRIs as lifesaving for some, advocating data-driven, nuanced risk–benefit conversations.

Risk–Benefit: Weighing Maternal vs. Fetal Outcomes

Risks of Untreated Depression

Data show untreated depression in pregnancy is linked to:

• Preterm birth
• Low birth weight
• Poor prenatal self-care
• Increased risk of postpartum depression—often more severe than antenatal depression.

These underscore the critical need for effective maternal treatment strategies.

Risks of Antidepressants

• Birth Defects: Small absolute increases, mostly with paroxetine, not all SSRIs.
• PPHN: Transient risk signals, lacking consistent evidence when adjusted for confounders.
• Neonatal adaptation syndrome: Largely mild—resolves often within 48 hours.
• Neurodevelopment: Inconsistent data; any potential effects require disentangling maternal illness, genetics, and environment.

Did the FDA Mislead?

Ultimately, the answer hinges on interpretation:

• Yes, if one thinks the FDA’s previous letter‑category system and cautious early framing fostered false reassurance.
• No, if one believes the agency has reasonably reflected evolving data and emphasized maternal health while avoiding unnecessary panic.

Regardless, key points emerge:

1. FDA’s early communications were incomplete, but should not be seen as deceitful.
2. Modern labeling (PLLR) is robust, yet may not reach all clinicians or patients—risking gaps in informed consent.
3. Present ambiguity stem from emerging evidence, not necessarily agency bias.

FDA’s Next Moves Post‑July 2025 Meeting

While no official changes have been released, the meeting signals:

• Possible stricter labeling for SSRIs if risk signals solidify.
• Greater emphasis on real-world data tracking via pregnancy registries.
• Potential development of comprehensive decision aids or tools for clinicians to guide risk–benefit discussions in “real time.”

Practical Guidance for Clinicians & Patients

1. Preconception Planning: Discuss mental health history and SSRI risks before pregnancy begins.
2. Careful Monitoring: If SSRIs continue, choose those with favorable safety profiles (e.g. sertraline, citalopram) and lowest effective dose.
3. Non‑Drug Strategies: Integrate therapy, lifestyle, and social support—particularly in mild-to-moderate cases.
4. Informed Consent: Provide up‑to‑date data: birth‑defect risks, neonatal syndrome probabilities, maternal relapse risks.
5. Postnatal Follow‑Up: Evaluate infant adaptation; offer pediatric check-ins and maternal support.

Conclusion

Did the FDA mislead? Not deliberately—but framing and clarity matters. Historically, limited categorization may have imparted false reassurance, while modern guidance is more nuanced—but not always understood or applied. The July 2025 FDA panel highlights intensifying pressure to revisit SSRI labeling and patient counseling frameworks.

Psychiatrists now stress one central principle: pregnancy therapy decisions are deeply personal, requiring:

• Awareness of both direct risks to the fetus and the potential harm of untreated maternal depression.
• Clinicians who are transparent, empathetic, and current in guidance.
• Balanced, data-informed narratives—neither panicky nor complacent.

Ultimately, the goal is to empower pregnant women with full, balanced information—so that each can make choices aligned with her values, health needs, and support systems.