FDA panel weighs risks, benefits of antidepressants during pregnancy

Key takeaways:

• Panel members said SSRI use during pregnancy has been tied to adverse fetal outcomes.
• An expert told Healio the risks of untreated depression “is greater than the risks of SSRIs.”

Members of an FDA expert panel discussed the risks and benefits of selective serotonin reuptake inhibitors, or SSRIs, for depression during pregnancy, with some calling for stronger warning labels.

According to ACOG, about one in 10 pregnant women face depression, which can increase the risk for early labor, low birth weight and postnatal health complications.

FDA Commissioner Martin Makary, MD, MPH, said SSRIs “can be an effective treatment for depression,” but he also said “serotonin may play a crucial role in the development of organs of a baby in utero,” including the heart, brain and gut. Further, he said “SSRIs have also been implicated in different studies to postpartum hemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects.”

However, Tiffany A. Moore Simas, MD, MPH, MEd, MHCM, a professor of OB/GYN, pediatrics, psychiatry and behavioral science and population & quantitative health sciences at the University of Massachusetts Chan Medical School, told Healio “it is incredibly important to present the risks of untreated perinatal mental health conditions, which in addition to having significant negative consequences for pregnant persons, offspring and families, are the leading cause of overall and preventable maternal mortality via suicide and overdose.”

“People don’t get to choose whether or not they have mental health conditions. They do get to choose how to treat them,” Moore Simas, who was not part of the panel discussion, said.

Adverse health outcomes

During the discussion, several panelists highlighted the potential negative outcomes associated with antidepressants, especially in newborns.

Anick Bérard, PhD, a professor of perinatal epidemiology at the University of Montreal, said SSRIs during pregnancy have been tied to a higher risk for spontaneous abortion, congenital malformations, prematurity, low birth weight and ADHD or autism, “with an increased risk ranging from 10% to 87%, depending on the adverse pregnancy outcome.”

According to Mayo Clinic, the link between autism and antidepressants during pregnancy warrants more research, “but most studies have shown that the risk is very small,” while some “have shown no risk at all.”

Other reports suggest that there are no significant associations between SSRIs and an increased risk for spontaneous abortion or ADHD, according to the MGH Center for Women’s Health.

Bérard added that SSRIs are “not the miracle solution” to depression because “12% of women who are using SSRIs remain depressed in pregnancy,” which she said could be attributed to “suboptimal use or inappropriate dosing.”

Additionally, Jay Gingrich, MD, PHD, director of the Institute for Developmental Sciences, said there is some evidence to suggest that prescribing SSRIs during pregnancy may worsen outcomes in offspring, including a greater risk for depression during adolescence.

Adam Urato, MD, chief of maternal-fetal medicine at MetroWest Medical Center, said there is “widespread scientific agreement” that SSRIs influence fetal brain development, and long-term studies have shown higher rates of speech and language difficulties in addition to autism and depression.

“If serotonin plays a crucial role in the fetal development, and it does, and if the SSRIs cross the placenta and disrupt the serotonin system, which they do, then the SSRIs must disrupt fetal development,” he said, noting that human and animal studies show “that SSRIs impact individual neurons in the developing brain.”

FDA warning labels need alteration

Urato said that “a big part of compassionate care is giving patients the proper information about risks and benefits of treatment and then supporting their choices.”

According to Urato, most women say they have been counseled only that SSRIs “do not affect the baby or cause complications.” 

He pointed out there is currently no warning for preeclampsia or preterm birth on the drug labels.

Literature on the link between preeclampsia and SSRIs is mixed. According to the MGH Center for Women’s Health, for example, a meta-analysis on nine studies revealed a small but statistically significant increased risk for preeclampsia in SSRI-exposed pregnancies. However, the center acknowledged that most studies do not account for preeclampsia risk factors, and it is “biologically possible” that antidepressants, which improve serotine regulation, may actually help “decrease vulnerability to preeclampsia.”

Regarding preterm birth, a 2024 study published in npj Women’s Health showed that antidepressants did not increase preterm birth risk. However, there was a 10% greater risk for women with a history of depression who did not take SSRIs during pregnancy vs. those without a history of depression.

Urato also said “the postpartum hemorrhage warning needs to be strengthened, but perhaps the major shortcoming is the label doesn’t make clear that SSRIs alter fetal brain development.”

Meanwhile, Josef Witt-Doerring, MD, a psychiatrist at Taperclinic, said that warning labels need to provide more information about tapering and the risk for withdrawal.

“Why are we not telling women about the risks of these medications and how challenging it can be to come off in a timely fashion?” he asked.

Witt-Doerring also pointed out inconsistencies when it comes to the medication guides of drugs within the same class.

“Lexapro may harm the unborn baby in one medication guide, [but] Zoloft does not emphasize that — it emphasizes withdrawal,” he said. “It doesn’t make sense that we should have inconsistent medication guide labeling.”

In a statement, ACOG said the panelists had many “outlandish and unfounded claims,” one of which is that “patients are deceived or inadequately counseled by their doctors.”

Untreated depression also raises risks

Kay Roussos-Ross, MD, a professor and director of the perinatal mood disorders program at the University of Florida College of Medicine, said “treating mental illness is not a luxury, it is a necessity,” and certain risks like preterm delivery are higher when women are not treated.

According to Roussos-Ros, perinatal mood disorders affect 20% of pregnant people in the U.S.

“Despite this prevalence, at least half of affected women go untreated or undertreated during their pregnancy and postpartum, and this is due to several reasons, including inadequate identification, inadequate access to care and stopping of medications for treatment,” she said.

In addition to preterm delivery, Roussos-Ross said the risks of untreated depression include small for gestational age and inadequate bonding and attachment, which can then decrease socialization in youth.

“When mental health conditions go untreated, these women are less likely to attend their prenatal care appointments and are more likely to use substances during their pregnancy,” she said. “They are also more likely to face additional risks such as preeclampsia and cesarian delivery.”

Roussos-Ross said suicide is another major risk “as one of the leading causes of maternal death in the U.S. is mental health.”

Although there are several effective treatment options, Roussos-Rose said SSRIs are among “the most-studied medications in pregnancy.”

“When we review the literature and account for confounding variables, comparing patients with depression who were untreated vs. patients who are with depression and medications, we actually see that the risks are very similar between the two groups” for most conditions, she said.

Based on current evidence, “which is agreed upon by many professional societies, the risks of untreated mental health are significant, and SSRIs should be considered as one of the treatment options with shared decision-making with our patients,” Roussos-Ross said.

Shared decision-making ‘essential’

Members repeatedly emphasized the need for shared decision-making between pregnant patients and health care providers.

“The importance of informed decision-making in pregnant women is essential,” Bérard said. “Pregnant women will be the ones making the decision, and they will be acknowledging the risks and benefits for themselves if it is well explained to them.”

Bérard said the prevalence of anxiety and pregnancy since the COVID-19 pandemic has more than doubled, which “warrants increased monitoring for both the mother and the children in the coming decade, particularly among those in the vulnerable population.”

Moore Simas told Healio that discussions about the risks of treatment “must be balanced with information about not treating.”

“The evidence on balance supports treatment, especially given early data have many limitations, including use of inappropriate comparison groups, and more contemporary advanced analytic methodologies have improved our ability to address confounding by indication and interpretation,” she said. “For most patients with active depression or anxiety symptoms, the risks of untreated disease [are] greater than the risks of SSRIs.”

Editor’s note: This is a developing news story. Please check back soon for more details.

References:

• Amit G, et al. npj Women’s Health. 2024;doi:10.1038/s44294-024-00008-0.
• Antidepressants: Safe during pregnancy?. Available at: Published July 22, 2025. Accessed July 22, 2025.
• ACOG Statement on the Benefit of Access to SSRIs During Pregnancy. Available at:  Published July 21, 2025. Accessed July 22, 2025.
• Depression during pregnancy. Available at: Accessed July 21, 2025.
• Does SSRI use in pregnancy raise the risk of depression in teens? Available at: Published May 6, 2025. Accessed July 21, 2025.
• Essential reads: SSRI antidepressants during pregnancy and risk of hypertension, preeclampsia. Available at: Published April 4, 2023. Accessed July 21, 2025.
• Essential reads: SSRI antidepressants do not increase risk of miscarriage. Available at: Published Jan. 6, 2021. Accessed July 22, 2025.
• No link between prenatal exposure to antidepressants and risk for ADHD in offspring. Available at: Published Jan. 3, 2023. Accessed July 22, 2025.
• Untreated depression increases preterm birth risk, not antidepressants. Available at: Published April 11, 2024. Accessed July 22, 2025.
• Zanni G, et al. Nat Commun. 2025;doi:10.1038/s41467-025-58785-4.

For more information:

Tiffany A. Moore Simas, MD, MPH, MEd, MHCM, can be reached at [email protected].