Antidepressants and Pregnancy: What the Updated Evidence Actually Says
Reviewed by Daniel Montville, MD, Psychiatrist
SiggyMD Clinical Team · Last updated June 4, 2026
Key Takeaways
- An FDA expert panel in July 2025 raised concerns about SSRIs in pregnancy, but ACOG, the APA, and MGH's Center for Women's Mental Health issued strong responses emphasizing that the panel provided an unbalanced picture and that robust evidence supports SSRI safety for most outcomes.
- Large meta-analyses and well-controlled studies have found no overall increased risk of birth defects, autism spectrum disorder, ADHD, or long-term neurodevelopmental harm with SSRI exposure. Older studies that found these associations failed to adequately control for the effects of untreated maternal depression itself.
- Untreated depression during pregnancy is not a neutral alternative. Mental health conditions account for over 23% of pregnancy-related deaths in the United States. Suicide attempts among pregnant and postpartum women nearly tripled over the past decade. Untreated depression is also associated with preterm birth, low birth weight, and impaired mother-infant bonding.
- Real but smaller risks do exist: neonatal adaptation syndrome (mild, self-resolving symptoms in up to 30% of exposed newborns), a very small increase in persistent pulmonary hypertension of the newborn, and a modest increase in postpartum hemorrhage risk near term. These do not typically outweigh treatment benefits for moderate-to-severe depression.
- Sertraline (Zoloft) is the first-line SSRI for pregnancy and breastfeeding in antidepressant-naive women, based on the largest evidence base for reproductive safety and lowest breast-milk excretion. Paroxetine should be avoided. The decision to start, continue, or change medication should always be individualized with prescriber guidance.
The question of antidepressants during pregnancy is not new. But the debate got louder in July 2025, when an FDA expert panel convened to discuss SSRI safety in pregnancy and, according to ACOG, the American Psychiatric Association, and major reproductive psychiatry centers, presented an account that missed half the clinical picture.
That missing half is the harm of untreated depression. And for patients who are pregnant, planning a pregnancy, or managing an unplanned pregnancy while on an antidepressant, understanding both sides of this evidence is what makes it possible to make an actual informed decision.
What This Page Covers
- What the current evidence says about SSRI safety in pregnancy
- Which specific risks are real and how large they are
- The documented harm of untreated perinatal depression
- Which antidepressant is preferred for pregnancy and breastfeeding
- What the 2025 FDA panel controversy was about, and how major clinical organizations responded
What the 2025 FDA Panel Said and Who Pushed Back
On July 21, 2025, the FDA convened an expert panel to discuss SSRI use in pregnancy. The panel raised concerns about potential adverse fetal outcomes and discussed stronger warning labels.
The clinical response was swift. ACOG stated that the panel “was alarmingly unbalanced and did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy” and affirmed that “robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects.”
What the Evidence Says About Specific Risks
This is where precision matters. Blanket statements in either direction misrepresent the data.
Birth defects overall: Large population-based studies in the United States and five Nordic countries have found no substantial increase in overall congenital malformations among infants exposed to SSRIs in utero. A 2025 NEJM analysis concluded that “data from studies explicitly addressing confounding by indication suggest that SSRI use during pregnancy carries little or no risk for the most serious adverse outcomes.”
Paroxetine (Paxil) specifically: Paroxetine is the exception among SSRIs. It carries an FDA Pregnancy Category D designation due to earlier data suggesting a small increase in cardiac malformations with first-trimester exposure. Paroxetine should be specifically avoided in pregnancy and is not recommended for women of childbearing age who are not on reliable contraception. The evidence for all other SSRIs does not carry this specific concern.
Autism and ADHD: This has been one of the most widely publicized concerns, and the better-controlled evidence does not support it. A 2022 study published in JAMA Internal Medicine compared data from nearly 146,000 women who took antidepressants when pregnant with data from more than 3 million women who did not, tracking children’s health for up to 14 years. Antidepressant use during pregnancy was not linked to autism, ADHD, behavior disorders, or problems with speech, language, learning, or coordination. Updated guidance from the University of Illinois DocAssist (2025) confirmed that new studies do not demonstrate an association between SSRI exposure and autism spectrum disorder, intellectual disability, or ADHD, noting that previous studies suggesting this association failed to control for maternal or paternal depression, which itself increases risk of ASD in offspring.
Preterm birth: A 2024 study in npj Women’s Health found that antidepressants did not increase preterm birth risk, but found a 10% greater risk for women with a history of depression who did not take SSRIs during pregnancy compared to those without a history of depression. The risk is in the untreated depression, not the medication.
Neonatal adaptation syndrome: This is a real and documented outcome. Up to 30% of newborns exposed to antidepressants in the third trimester show signs of neonatal adaptation syndrome: irritability, jitteriness, tremors, mild feeding difficulty, or respiratory changes. In the great majority of cases, these symptoms are mild and self-limiting, resolving within days to two weeks without treatment. Discontinuing SSRIs shortly before delivery has not been shown to reduce the risk of neonatal adaptation syndrome, so stopping medication at the end of pregnancy specifically to prevent this outcome is not recommended.
Persistent pulmonary hypertension of the newborn (PPHN): There is a small association. PPHN incidence increases from approximately 2 per 1,000 in the general population to approximately 3 per 1,000 in infants exposed to antidepressants, and this difference may not be significant after adjusting for confounders. The absolute risk is very small.
Postpartum hemorrhage: SSRI use near delivery modestly increases postpartum hemorrhage risk due to serotonin’s role in platelet aggregation. The magnitude is uncertain and should be discussed with the obstetric team. This is not a reason to stop medication without clinical guidance.
What Untreated Depression Actually Costs
The July 2025 FDA panel was criticized specifically for analyzing medication risks in isolation. Here is the other side of that ledger.
Mental health conditions, including suicide and overdose, are the leading cause of pregnancy-related death in the United States, accounting for over 23% of maternal mortality. Suicide attempts among pregnant and postpartum women nearly tripled over the past decade.
Women with perinatal depression are more than twice as likely to die compared to women who do not have perinatal depression, with a nearly six-fold increase in suicide risk. Despite this, 75% of women affected by maternal mental health conditions remain untreated.
Untreated depression during pregnancy is also associated with preterm birth, low birth weight, substance use, poor prenatal care engagement, impaired bonding with the infant, and increased risk of postpartum depression. The clinical framing that matters is not “Is the medication safe?” but “What is safer: treating or not treating?” For patients with moderate-to-severe depression, the answer from the evidence is consistent. ACOG guidelines strongly recommend against withholding or discontinuing medications for mental health conditions due to pregnancy or lactation status alone.
Which Antidepressant Is Preferred in Pregnancy
If medication is indicated, the evidence supports sertraline (Zoloft) as the first-line choice for antidepressant-naive patients.
Sertraline is the drug of choice in pregnancy and breastfeeding for patients who have not previously taken antidepressants, based on the largest evidence base for reproductive safety and lowest excretion into breast milk among SSRIs. Large population-based studies have found no increased risk of cardiac malformations with first-trimester sertraline use.
For patients already stable on a different antidepressant, the risk of switching during pregnancy often outweighs the benefit. Changing medications introduces a new exposure and the risk of clinical destabilization during a vulnerable period. The best medication in pregnancy is often the one that works best for the individual patient. Paroxetine should be avoided. No other SSRI carries a comparable specific contraindication.
Breastfeeding and Antidepressants
Antidepressants enter breast milk at less than 10% of the maternal dose. Sertraline has the lowest breast-milk excretion among the commonly used SSRIs and is the preferred choice for breastfeeding mothers.
The Canadian Paediatric Society confirmed that low levels of SSRIs excreted in breast milk are compatible with breastfeeding and that mothers should be encouraged and supported to breastfeed their infants during treatment with an SSRI. Breastfed infants exposed to SSRIs during the third trimester actually show a lower rate of neonatal adaptation symptoms than formula-fed infants in the same situation.
The Decision Framework: What to Bring to Your Prescriber
The question is not whether antidepressants carry any risk in pregnancy. They carry some. The question is whether those risks are greater than the documented risks of untreated illness in your specific clinical situation.
That evaluation depends on your history: the severity and recurrence pattern of your depression, your prior medication response, how far along the pregnancy is, and whether psychotherapy alone has been effective before. It requires a conversation that involves your prescriber and your OB, ideally before pregnancy if you are planning one.
“The most dangerous thing I can imagine is a pregnant patient stopping her antidepressant abruptly after seeing alarming headlines, without talking to anyone,” says Daniel Montville, MD, Psychiatrist at SiggyMD. “She is not protecting her baby. She is removing the treatment that is keeping her stable during one of the highest-risk periods in the psychiatric calendar. The conversation should always start with: what are we actually treating, how severe is it, and what is the documented risk of going without that treatment?”
If you are in crisis or experiencing thoughts of suicide, call or text 988 immediately. If you are in immediate danger, call 911.
What Members Are Saying
KP
K.P., 31
Generalized Anxiety and Depression
“I found out I was pregnant while on escitalopram and panicked. I called my prescriber immediately, and she walked me through the evidence. We switched to sertraline and she coordinated with my OB. My daughter is now 18 months old and completely healthy. Looking back, stopping abruptly out of fear would have been the worst decision I could have made.”
AW
A.W., 37
Recurrent Major Depressive Disorder
“I had severe depression in my first pregnancy and did not take medication. I spent most of those nine months barely functional. With my second pregnancy, I stayed on sertraline the entire time. The difference in my ability to take care of myself and bond with my baby was night and day. The medication was not the risk. The untreated depression was.”
Member stories reflect real experiences. Names and identifying details have been changed to protect privacy. Results vary. SiggyMD is currently invite-only.
Bottom Line
The current evidence, reviewed by ACOG, the APA, and the MGH Center for Women’s Mental Health in direct response to the July 2025 FDA panel, supports the following conclusions: SSRIs do not increase overall birth defect risk; the autism and ADHD associations from older studies were artifacts of inadequate confounding control; and untreated depression poses serious, documented risks to both the pregnant person and the developing child that often outweigh the manageable, smaller risks associated with SSRIs.
The decision about antidepressants in pregnancy is individualized. It requires clinical guidance and honest conversation between you and your care team. It cannot be made from a headline.
Start your anonymous intake with SiggyMD, where a licensed prescriber reviews every clinical decision and daily check-ins make it possible to monitor both mood and medication response through the full arc of care, including pregnancy planning and postpartum.
Sources
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ACOG. Statement on the Benefit of Access to SSRIs During Pregnancy. American College of Obstetricians and Gynecologists. July 2025.
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American Psychiatric Association. Letter to FDA Commissioner on SSRIs and Pregnancy Panel. APA. July 2025.
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Batt MM, et al. Untangling the Risks of Antidepressants in Pregnancy. New England Journal of Medicine. 2025.
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Petrosellini C, et al. The Use of Psychotropic Medication in the Perinatal Period. The Obstetrician and Gynaecologist. 2024.
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Harvard Health Publishing. Expectant Mothers Can Rest Easier About Taking Antidepressants. Harvard Medical School. 2022.
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University of Illinois DocAssist. Information for Providers on Antidepressants During Pregnancy and Breastfeeding. Illinois DocAssist. January 2025.
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Amit G, et al. Antidepressants and Preterm Birth. npj Women’s Health. 2024.
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Canadian Paediatric Society. SSRIs or SNRIs in Pregnancy: Infant and Childhood Outcomes. CPS. 2024.
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Policy Center for Maternal Mental Health. Maternal Mental Health Fact Sheet. Accessed June 2026.
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Admon LK, et al. Trends in Suicidality Among Insured Pregnant and Postpartum Women. Psychiatric Times. 2021.
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NCBI LactMed. Sertraline: Drugs and Lactation Database. Accessed June 2026.
Frequently Asked Questions
Is it safe to take antidepressants during pregnancy?
For most patients with moderate-to-severe depression, the benefits of continuing antidepressant treatment during pregnancy outweigh the risks. Large meta-analyses have found no overall increase in birth defects or long-term neurodevelopmental harm with SSRI exposure. Real but smaller risks include neonatal adaptation syndrome (usually mild and self-resolving), a very small increase in persistent pulmonary hypertension, and a modest increase in postpartum hemorrhage. Untreated depression during pregnancy carries its own serious risks, including preterm birth, low birth weight, impaired bonding, and increased maternal suicide risk. The decision requires individualized assessment with your prescriber and OB.
What is the safest antidepressant during pregnancy?
Sertraline (Zoloft) is considered the first-line antidepressant for pregnancy and breastfeeding in women who are starting treatment for the first time, based on the largest evidence base for reproductive safety and very low breast-milk excretion. Paroxetine (Paxil) is specifically avoided due to historical cardiac malformation concerns with early-trimester exposure. If you are already stable on a different antidepressant, the risks of switching medications during pregnancy may outweigh the potential benefits of switching to sertraline. Your prescriber will make this assessment.
Does taking antidepressants during pregnancy cause autism?
Well-controlled studies do not support a causal link between SSRI exposure in pregnancy and autism spectrum disorder. Earlier studies that found an association failed to adequately account for the fact that maternal depression itself increases the risk of autism and neurodevelopmental problems in offspring. A 2022 study published in JAMA Internal Medicine compared nearly 146,000 antidepressant-exposed pregnancies to over 3 million unexposed pregnancies and tracked children for up to 14 years, finding no link to autism, ADHD, behavior disorders, or speech and language problems.
What is neonatal adaptation syndrome and is it serious?
Neonatal adaptation syndrome (NAS) refers to a cluster of symptoms that can appear in newborns exposed to SSRIs near the end of pregnancy: irritability, jitteriness, tremors, feeding difficulty, and mild respiratory changes. It occurs in up to 30% of exposed newborns. In most cases, symptoms are mild, self-limiting, and resolve within days to two weeks without treatment. Discontinuing SSRIs shortly before delivery does not appear to reduce the risk. Hospital staff are familiar with monitoring and managing NAS in newborns.
Should I stop antidepressants if I get pregnant?
Do not stop antidepressants abruptly without speaking to your prescriber. Abrupt discontinuation can cause withdrawal symptoms and significantly increases the risk of relapse, which carries its own risks during pregnancy. For patients with a history of severe or recurrent depression, continuing medication is generally the recommended course. For patients with mild depression who have been stable for six months or more, a supervised taper may be considered. This decision should involve both your prescriber and your OB, ideally before pregnancy if possible.
Can I breastfeed while taking an antidepressant?
Most SSRIs are compatible with breastfeeding. Antidepressants enter breast milk at less than 10% of the maternal dose. Sertraline has the lowest breast-milk excretion of the commonly used SSRIs and is considered the preferred choice for breastfeeding mothers. The benefits of breastfeeding are well established and should not be abandoned due to SSRI use without discussion with your prescriber and pediatrician. Infants born to mothers who took an SSRI during pregnancy and who are breastfed actually show a lower rate of neonatal adaptation symptoms than formula-fed infants in the same situation.
What did the 2025 FDA panel say about SSRIs and pregnancy?
An FDA expert panel convened in July 2025 raised concerns about potential fetal development effects of SSRIs during pregnancy. The panel was criticized by ACOG, the American Psychiatric Association, and the MGH Center for Women's Mental Health for presenting an unbalanced picture that did not adequately represent the risks of untreated perinatal depression. ACOG stated that 'robust evidence has shown that SSRIs are safe in pregnancy and that most do not increase the risk of birth defects.' Both ACOG and the APA emphasized that withholding effective mental health treatment during pregnancy carries documented and serious risks for both mothers and infants.
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