August 14, 2025
5 min read
Key takeaways:
- An FDA panel recently raised concerns over antidepressant use during pregnancy.
- An expert said these treatments’ effectiveness are well-documented and risks for adverse effects are low.
Members of an FDA expert panel last month discussed the risks and benefits of using selective serotonin reuptake inhibitors, or SSRIs, for depression during pregnancy.
The panelists questioned the safety and efficacy of SSRIs, with some saying they increase the risk for birth defects and pregnancy complications.
An FDA panel recently raised concerns over antidepressant use during pregnancy. Image: Adobe Stock
Outside experts condemned many of the panelists’ claims, including ACOG, which called them “outlandish and unfounded.”
Healio spoke with 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, to learn more about the evidence behind SSRIs during pregnancy, how health care providers should weigh the risks against benefits and more.
Healio: ACOG said the panelists had many “outlandish and unfounded claims.” What are the ones that stick out to you the most?
Moore Simas: In general, not contemporary or incomplete data were cited in many cases. I will say that many survivors of perinatal mood and anxiety disorders reached out to me and others, and they were really triggered, in particular by one of the panelists, Dr. Jeffrey Lacoste, who implied that women’s higher rates of depression reflect a “gift of emotional sensitivity.” I think it minimized and dismissed the lived experiences of those with a perinatal mental health condition as a health event.
When we talk about perinatal mental health conditions, we’re talking about psychiatric diseases and illness. We’re not talking about a range of normal or even expanded emotions. We’re talking about mental health conditions that meet criteria of the American Psychiatric Association as being a psychiatric disorder. So, it is ignored that there is a biologic underpinning to this, that there are reproductive hormones that we call neuroactive steroids that have direct binding sites in the brain that influence emotion, regulation and stress responses.
It is not a coincidence that rates of mood disorders, depression and anxiety change, and that there is a difference between men and women at the start of puberty.
When I think about those who have lived the experience of parental mental health conditions and those who are survivors of them, many felt as if they were being gaslit or harkened back to a time of ancient medicine when we incorrectly believed that this sort of “wandering womb” or uterus can cause psychological and physical symptoms in women. That is one of the derivations of hysterectomy, surgical removal of the uterus, and in the past was associated with removing a woman’s uterus to remove the hysteria. Referring to mental health conditions as a “gift” minimized the fact that there are established biologic reasons why women have higher rates of depression than men across the life course and that there are significant negative impacts.
Healio: How do SSRIs impact fetal development? How strong is the evidence?
Moore Simas: If you look at the well-designed studies, you’ll find the risks of adverse effects from SSRI use in pregnancy are very low, especially when you account for underlying maternal illness, severity of illness and other important potential confounders. Some of the early studies took healthy women without mental health conditions and compared them with women with mental health conditions on SSRIs. That’s not the appropriate comparison group because you’re not going to be on an SSRI if you don’t have a mental health condition. And mental health conditions themselves are associated with significant negative consequences for the pregnant person, the pregnancy and the offspring.
So, we really need to think about what the risks of untreated disease are when we’re talking about fetal development. Some of the early studies using the wrong comparison group looked at things like congenital anomalies, miscarriage or stillbirth, for example. But the available data using the right comparison group and controlling for potential confounders do not support an overall increased risk of major congenital malformations, and that includes cardiac malformations. Similarly, there has not been a causal association with miscarriage or stillbirth.
Healio: How do SSRIs impact pregnant women? How strong is the evidence?
Moore Simas: SSRIs are well documented to be clinically effective in treating depressive disorders and anxiety disorders. Untreated diseases themselves are associated with miscarriage, gestational diabetes, gestational hypertension, preeclampsia, preterm birth and infants who are small for gestational age; additionally, there are associations with delayed offspring development and an increased risk of psychiatric disorders for a child later in life.
SSRIs are effective in treating depressive disorders and anxiety disorders, and not treating these conditions in pregnancy and the postpartum period come with significant negative impact that is multigenerational. Often, treatment doesn’t happen because of fear of fetal harm or stigma surrounding the use of medications during pregnancy. So, the false information and narrative is part of the problem.
Healio: What are some examples of how the benefits of SSRIs outweigh the risks? What should doctors consider when weighing these risks and benefits?
Moore Simas: You need to have a balanced conversation. So often people talk about the risk of the medication and talk about these risks in a way that is inaccurate, as we heard in many instances in the panel. However, they don’t ever talk about the risk of not treating the disease. I just shared information on the risks of untreated disease, which far outweigh the risks of treating the disease. Now, treatment doesn’t always need to be medications, and in fact, psychotherapy is the first line treatment in many cases. However, in many cases, medication is needed and appropriate. So, it’s really a balance in sharing the information, having a balanced conversation around the risks or detrimental impacts of untreated or undertreated diseases and the risk of treatment. Treatment approaches and recommendations take into account the severity of disease, access to different kinds of treatment and patient preference.
Healio: What is the take-home message for physicians?
Moore Simas: SSRIs are well documented to have clinical efficacy in treating depression and anxiety disorders; they’re some of the most studied medications in pregnancy. We heard there aren’t randomized trials, and that’s true. However, if we look at all the medications we use in pregnancy, these are some of the most studied, and the data are very reassuring. When you use the full body of available evidence of well-designed studies, the risks of adverse effects from using SSRIs during pregnancy are very low. Also, we must balance that with the known knowledge that untreated psychiatric diseases themselves have very significant risks for the pregnant woman and her offspring.
References:
For more information:
Tiffany A. Moore Simas, MD, MPH, MEd, MHCM, can be reached can be reached at [email protected].
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