Warning or Weapon? What the FDA’s Shift on Antidepressants in Pregnancy Really Signals
By Amanda Rabinowitz PhD
Last week, a panel convened by the FDA reopened an old question: Should antidepressants carry stronger warnings for pregnant people? On its face, this might seem like a well-intentioned effort to protect babies. But let’s be clear. This measure is not about promoting health. It’s about controlling women’s bodies.
Over nearly four decades, countless studies have examined whether antidepressants harm developing fetuses. The consensus, backed by rigorous evidence and the lived experience of countless patients and clinicians, is that the risks associated with pharmacotherapy treatment are outweighed by a greater threat of untreated depression. Untreated depression and anxiety in pregnancy are not minor inconveniences; they are major threats to the health of the pregnant person and the baby alike. Depression increases the risk of substance use, missed prenatal care, premature birth, and even suicide, which is on the rise as a leading cause of maternal mortality in the U.S.
Yet, instead of focusing on expanding mental health care and ensuring pregnant people can access safe, effective treatment, the Trump administration seeks to turn back the clock. The shift toward stronger warnings is not about patient safety; it’s about reinforcing a worldview that sees women first and foremost as vessels for reproduction. It’s the same worldview that underpins the rollback of abortion rights, the assault on gender-affirming care, and the policing of who gets to make decisions about their own body and health.
The panel convened last week was not a good-faith effort to gather experts in mental health, neonatal, and maternal care. The American College of Obstetricians and Gynecologists (ACOG) called out the FDA’s panel as “alarmingly unbalanced.”
Here’s how Steven J. Fleischman, MD, MBA, FACOG, and president of ACOG, put it:
“Today’s FDA panel on SSRIs and pregnancy was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy. On a panel of ten experts, only one spoke to the importance of SSRIs as a critical option for preventing the potentially devastating effects of anxiety and depression when left untreated during pregnancy.
Robust evidence shows that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects. Meanwhile, untreated depression can raise the risk of substance use, preterm birth, preeclampsia, poor engagement in prenatal care, low birth weight, impaired bonding with the infant, and even suicide. Discontinuing SSRIs during pregnancy or lactation can also be dangerous. Patients need access to evidence-based, compassionate treatment so they can pursue parenthood with both physical and mental well-being. For pregnant people who need SSRIs, they are life-changing and lifesaving.”
Yet instead of centering this evidence, this administration seems determined to undermine psychiatry and evidence-based mental health care. They echo the same conspiratorial blend of right-wing ideology and wellness culture that reduces real mental illness to mere moral or spiritual failings — problems supposedly fixed by “getting fresh air” or “finding a hobby.” This mindset is exemplified by RFK Jr.’s broader skepticism toward antidepressants. Reducing access and promoting fear and hesitancy among expecting parents is just one step on a larger path toward undermining access to psychiatric medication more broadly. Yes, there are valid debates to be had about overprescribing and how to expand access to non-pharmacological care. But a sweeping, ideologically-driven black box warning is not a good-faith solution.
A black box warning on antidepressants in pregnancy won’t empower patients. It will shame them. It will push them away from treatment that could save their lives and their babies’ lives. It will build yet another barrier between people and the care they deserve in a fragmented maternal health system that already fails too many mothers.
If this administration truly cared about maternal and infant health, it would invest in making high-quality, evidence-based mental health care accessible to every pregnant person, not just the lucky few. It would expand reproductive health care, not erode it. It would trust pregnant people to work with their doctors to weigh the real risks and benefits for themselves and their families, instead of dictating decisions from on high to score political points with anti-science ideologues.
Reproductive freedom means more than the right to end a pregnancy. It also means the right to continue a pregnancy safely and with dignity, supported by the full range of medical care– including mental health treatment. When policymakers undermine that right, they send a clear message: Your life, your mind, your health don’t matter as much as your womb.
We should all be alarmed by where this is heading. Because once we accept that politicians can decide whether a depressed mother gets treatment, we’ve opened the door to more and more political interference in deeply personal, deeply medical decisions. For pregnant people. For trans people. For anyone whose body has become a battleground in America’s culture wars.
We deserve better than fear-based warnings and performative moral panic. We deserve a health care system that treats people as whole people– not vessels to be regulated.
Recommended references:
Modest, A. M., Prater, L. C., & Joseph, N. T. (2022). Pregnancy-associated homicide and suicide: An analysis of the national violent death reporting system, 2008–2019. Obstetrics & Gynecology, 140(4), 565-573.
Forray A, Yonkers KA. The collision of mental health, substance use disorder, and suicide. Obstet Gynecol. 2021 Jun 1;137(6):1083-1090. doi: 10.1097/AOG.0000000000004391. PMID: 33957654.
Jahan, N., Went, T. R., Sultan, W., Sapkota, A., Khurshid, H., Qureshi, I. A., & Alfonso, M. (2021). Untreated depression during pregnancy and its effect on pregnancy outcomes: a systematic review. Cureus, 13(8).
Desaunay, P., Eude, LG., Dreyfus, M. et al. Benefits and risks of antidepressant drugs during pregnancy: A systematic review of meta-analyses. Pediatr Drugs 25, 247–265 (2023). https://doi.org/10.1007/s40272-023-00561-2
About the Author:
Dr. Amanda Rabinowitz is a brain injury neuropsychologist and a member of the leadership team at Philadelphia Science Action.