Potential risks for expectant mothers and their babies from SSRI antidepressants should be more fully disclosed in prescribing information and in discussions between physicians and their pregnant patients, experts say, allowing for more informed decisions about starting or stopping the drugs during pregnancy.

A 10-member FDA expert panel, headed by FDA Commissioner Martin Makary, MD, MPH, met in July to voice concerns over research in recent years linking the use of selective serotonin reuptake inhibitors (SSRI) antidepressants during pregnancy to potentially serious side effects for mothers and their newborns.  Panelists called for higher quality research on this potential connection, and stronger warning labels on SSRI antidepressants in the meantime, so physicians and pregnant patients can make more informed decisions about use of the drugs.

In his opening remarks, Dr. Makary said it is estimated that one in four (25%) middle-aged women and up to one in 20 (5%) of women in pregnancy are on an antidepressant.  He noted more generally that “we’re losing the broader battle of addressing mental health in the United States,” and “in some respects, we are going backwards.” 

“From a national standpoint, the more antidepressants we prescribe, the more depression there is,” he observed.  His solution: “We have to start talking about root causes.”

Data from recent surveys support this overview of antidepressants.  The use of antidepressants among adults in the U.S. has increased steadily from 9.8% in 2019 to 11.4% in 2023, according to data from the latest National Health Interview Survey, administered by the Centers for Disease Control and Prevention’s National Center for Health Statistics.

Concurrently, the rate of American adults who reported feeling depressed or receiving treatment for depression jumped by nearly 50%, from 12.5% in 2019 to 18.3% in 2025, a recent Gallup poll revealed.  The most recent rate amounts to an estimated 47.8 million adults in the U.S. feeling depressed.

During the panel’s discussion, members offered a range of opinions on the issue, with most arguing against SSRI use in pregnancy because of potential negative outcomes for mothers and their babies.

Dr. Makary referred to research studies implicating the role of SSRIs in postpartum hemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects.

Adam Urato, MD, chief of maternal and fetal medicine at MetroWest Medical Center in Framingham, Massachusetts, expressed concern that SSRI labeling “does not make clear that SSRIs alter fetal brain development.” 

“Many, many studies show an impact on the developing brain,” he explains. “We can see it on prenatal ultrasound.  The ultrasound studies show SSRI-exposed fetuses have different movement and behavior patterns.  After birth, the newborn babies can have jitteriness, breathing difficulties, and higher rates of admission to neonatal intensive care unit.”

“What are we waiting for before we warn the public?” he asks.  “Never before in human history have we chemically altered developing babies like this, especially the developing fetal brain.  And this is happening without any real public warning.”

Psychiatrist and psychopharmacologist David Healy, MD, a Fellow of the Royal College of Psychiatrists and CEO of Data Based Medicine in North Wales, pointed to his research, which suggests a link between SSRI use in pregnancy and autism and other developmental delays in infancy, leading to cognitive difficulties in childhood.  He explains that SSRIs’ core action is to mute sensory input, which can be a feature of autism.

Anick Berard, PhD, professor of perinatal epidemiology at the University of Montreal, spoke about the higher risk of miscarriage, congenital (especially cardiac) malformations, premature births and low birth weight, ADHD, or autism following SSRI use by expectant mothers.

Psychiatrist Jay Gingrich, MD, PhD, director of the Institute for Developmental Sciences at Columbia University Irving Medical Center in New York City, pegged the estimated rate of American women using an antidepressant during pregnancy at 8% to 10%, which equates to 320,000 to 400,000 live births annually that have been exposed to the drugs in utero.  He spoke about the results of his research, published earlier this year, which indicated that adolescents exposed to SSRIs as fetuses exhibited higher anxiety and depression symptoms in adolescence than adolescents who were not exposed.

Joanna Moncrieff, MD, a psychiatrist and professor of critical and social psychiatry at the University College London, said her research found that claims of SSRI antidepressant effectiveness are not supported by scientific evidence, which raises the question of whether antidepressants should be prescribed at all.  She theorizes that the emotional numbing caused by SSRIs “might reduce the intensity of people’s depressive symptoms or anxiety temporarily,” but that’s very different from taking a drug because you believe it is correcting some underlying brain abnormality.

Dr. Moncrieff states unequivocally that “antidepressants do not correct a chemical imbalance or any other underlying biological abnormality.”  As for effectiveness, they “do not work – are barely distinguishable from a placebo in clinical trials.” 

Further, “they disrupt normal brain chemistry causing a variety of harmful effects,” including sexual dysfunction (which can be persistent), miscarriage, premature delivery, postpartum hemorrhage, fetal malformations, and newborns experiencing withdrawal symptoms or persistent pulmonary hypertension.

She says that “advice and research on these drugs is hugely skewed by the pharmaceutical industry marketing and the professional interest to defend antidepressants.”

Kay Roussos-Ross, MD, a psychiatrist and director of the Perinatal Mood Disorders Program at the University of Florida College of Medicine, believes that the risk of these serious negative outcomes is low, except for the withdrawal symptoms – such as jitteriness, irritability, and respiratory distress – experienced by 25% to 30% of babies exposed to SSRIs late in pregnancy, and that the potential harm of untreated depression in mothers should be balanced against the potential risks of harm to their babies from SSRI use.

However, antidepressants are not the only treatment available for depressed patients during pregnancy.  Many of the panelists urged greater use of evidence-based alternative treatment options, which avoid potential risks to mothers and babies from the drugs altogether.

Panelists agreed that more research needs to be done on SSRI use during pregnancy, but that potential adverse effects indicated in existing research need to be more fully disclosed and alternative treatments considered in discussions between physicians or other health providers and their pregnant patients, prior to recommending or prescribing SSRI antidepressants.

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Anyone wishing to discontinue or change the dose of an antidepressant or other psychiatric drug is cautioned to do so only under the supervision of a physician because of potentially dangerous withdrawal symptoms or other complications.