SSRIs in Pregnancy: FDA’s Blind Spot and the Battle Over Maternal Mental Health

She thought she was doing the right thing.

At 29, newly married and planning to start a family, her physician reassured her that staying on an SSRI would be safe during pregnancy. Months later, she discovered she had been pregnant for nearly six weeks before she even realized it — all while taking the drug daily. No one had told her that stopping could require months of careful tapering. No one had explained the chemical’s impact on the developing brain of her unborn child.

That gap — between what women are told and what the science increasingly suggests — was at the center of a contentious FDA expert panel on the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy. What emerged was less consensus than confrontation: a collision of industry narratives, conflicting data, and regulatory blind spots.

The Scale of the Problem

The stakes are enormous. In the U.S. and Canada, about 5–6% of pregnant women are prescribed antidepressants, most of them SSRIs. Broaden the lens, and one in five women will suffer a perinatal mood disorder. As Commissioner Dr. Marty Makary put it bluntly:

“The more antidepressants we prescribe, the more depression there is. The more insulin we prescribe, the more diabetes there is. The more pain meds we prescribe, the more pain there was.”

Makary wasn’t suggesting causality. His point was structural: America is losing the battle against chronic disease because regulators and industry focus on pharmacology while ignoring root causes — community, light exposure, and social support. In pregnancy, this imbalance becomes even more dangerous because serotonin isn’t just a mood regulator. It is a key embryonic signal shaping the development of the fetal heart, brain, and gut.

The Regulatory Blind Spot

If the thalidomide tragedy of the 1960s was supposed to usher in an era of protection for pregnant women, SSRIs have quietly exposed a loophole: no randomized controlled trials exist for antidepressants in pregnancy. Labeling gaps is glaring. As panelist Dr. Adam Urato, Chief of Maternal-Fetal Medicine at MetroWest Medical Center, pointed out:

• No warnings about preterm birth or preeclampsia
• A watered-down postpartum hemorrhage warning
• Nothing about neurodevelopmental impacts

Urato’s frustration was palpable:

“These drugs alter the mom’s brain. Why wouldn’t they affect the babies? Chemicals have consequences.”

He cited 12 consecutive MRI studies showing altered fetal brain structure and function following prenatal SSRI exposure. Yet U.S. labels remain silent. For regulators, this is more than a scientific oversight — it’s a credibility crisis. Urato indicated that never before in human history have we chemically altered developing babies like this, and this is happening without any real public warning.

Mechanistic Red Flags

Basic science offers little comfort. Dr. Michael Levin, a developmental biologist at Tufts, described serotonin as an “ancient signaling modality” used by embryos to orient left-right asymmetry, guide neural crest migration, and regulate organogenesis. In his lab, blocking serotonin transport in frog embryos disrupted 40% of normal left-right organ development.

In mammals, similar signals control cell division, adhesion, and calcium flux — foundational steps in building the fetal nervous system. Interfering with serotonin during pregnancy, Levin warned, is not a targeted intervention. It is a system-wide disruption.

Meanwhile, Dr. Jay Gingrich of Columbia University shared human data. In Finnish registry studies, children exposed to SSRIs in utero showed higher rates of depression by adolescence. In MRI-based studies, SSRI-exposed children displayed greater amygdala reactivity to emotional faces, predicting poorer outcomes one year later. Gingrich indicated that while hope for maternal treatment would improve outcomes for the offspring, so far, there isn’t evidence that it does and may worsen them.

Industry Influence and the “Chemical Imbalance” Myth

If the biology raises red flags, the marketing history raises alarms. Dr. Jeffrey Lacasse, Florida State University, reminded the panel that much of SSRI prescribing rests on a debunked theory: that a serotonin deficiency causes depression.

In a survey of 1,100 Americans, 88% still believe depression is caused by a chemical imbalance — a belief shaped by decades of pharmaceutical advertising, including Zoloft’s famous “sad blob” campaign. Nearly half of women of childbearing age who were prescribed SSRIs said their doctor explicitly told them they had a chemical imbalance.

It was a powerful reminder: FDA labeling doesn’t just regulate risk, it also frames public understanding. And right now, women are entering pregnancy with myths, not facts.

Betrayal and Withdrawal

For some women, the betrayal comes late. Dr. Josef Witt-Doerring, a former FDA medical officer, now helps patients taper off antidepressants. He described women who had been on SSRIs for a decade, only to discover risks when they began planning a family.

“They feel incredibly betrayed… why didn’t anyone bring this up with me when I started the medication?”

Withdrawal itself is another blind spot. Some women require a year or more to taper safely, making pre-pregnancy planning even more complicated. Witt-Doerring suggested practical solutions, like QR codes on pill bottles linking to plain-language video warnings.

The irony: FDA requires such warnings on cigarettes, but not on drugs that freely cross the placenta and alter fetal brain chemistry.

The Counterpoint: Untreated Depression Also Kills

Not all panelists urged alarm. Dr. Kay Roussos-Ross, Professor at the University of Florida, stressed that untreated depression carries real risks: preterm birth, poor bonding, substance use, and suicide. Women who stop SSRIs during pregnancy are five times more likely to relapse.

“Treating mental illness in pregnancy is not a luxury, it’s a necessity”

Her position reflects professional society guidelines. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both support the use of SSRIs as a treatment option during pregnancy, emphasizing the importance of shared decision-making.

But here too lies the problem: shared decision-making requires transparent data, not sanitized labels. Without that, choice is an illusion.

The Efficacy Question

The most controversial challenge came from Dr. Joanna Moncrieff of University College London. She argued the entire risk-benefit equation collapses if SSRIs don’t actually work. Moncrieff indicated that antidepressants have never been shown to reduce suicide, and the difference between drug and placebo in depression trials is minuscule — about two points on a 52-point scale.

For her, the question isn’t whether SSRIs cause harm in pregnancy — they undoubtedly can. It’s whether they deliver any benefit that justifies that risk.

Litigation, Labels, and the Next Thalidomide?

Panelist Dr. David Healy, who testified in Paxil litigation that cost GSK over $1 billion, drew a straight line from animal studies to human outcomes. “Any drug that causes birth defects will cause autism spectrum disorder,” he said, citing consistent animal findings of “autistic-like” behavior in SSRI-exposed rodents.

Healy was blunt about the FDA’s complicity by indicating that the FDA doesn’t write labels. He mentioned that companies write them. The FDA looks over them and says there’s nothing terribly wrong, according to Healy.

It was a chilling reminder: FDA’s reliance on industry-submitted data, without independent verification, leaves both regulators and patients flying blind.

Why This Matters for Sponsors, Sites, and Regulators

The panel was less about a single drug class and more about systemic risk:

1. Regulatory Credibility: FDA risks repeating the playbook of opioids and thalidomide — slow recognition, industry influence, and eventual public outrage.
2. Litigation Exposure: As with Paxil, sponsors face billion-dollar liability if evidence of fetal harm is ignored in labeling and informed consent.
3. Trial Design Blind Spot: Pregnant women remain excluded from randomized trials, creating data vacuums that only litigation and registries fill.
4. Ethical Duty of Informed Consent: Sites must ensure women understand not only the risks of untreated depression, but also the mechanistic evidence of fetal impact — even when FDA labels remain silent.
5. Alternative Modalities: From psychotherapy to transcranial magnetic stimulation, non-pharmacologic interventions deserve rigorous trial investment to reduce reliance on drugs with mechanistic fetal risk.

The Takeaway: Time to Break the Silence

By the panel’s end, one truth was clear: SSRIs in pregnancy are not a settled science, but a regulatory gamble. Pregnant women, their infants, and the clinicians who care for them are being asked to navigate blindly.

Commissioner Makary framed the stakes by indicating that we have to stop and look at the big picture — some women are not aware of these potential health concerns, and sometimes these women don’t know they’re pregnant in the first trimester, and it takes time to wean off antidepressants like SSRIs.

Learning, however, is not enough. Without transparent labeling, stronger warnings, and independent trials, women will continue to discover too late what regulators already know: serotonin is not a benign target in pregnancy.

The question is whether the FDA will act now — or whether it will wait, as it has before, until another generation of families pays the price.