At a meeting held by the Food and Medicines Administration on July 21, 2025, a panel called by the Agency questioned the safety of antidepressant medications called selective serotonin reuptake inhibitors, or SSRIs, in pregnancy.
The panel members discussed add a call warning of black box to medicines, which the agency uses to indicate serious or potentially mortal side effects, about the risk they represent for developing fetuses. Some of the panelists who attended had a history of expressing deep skepticism about antidepressants.
Irsal include medications such as Prozac and Zoloft and are the most used medications to treat clinical depression. First line medications are considered to treat depression in pregnancy, and approximately 5% to 6% of North American women take an SSRIs during pregnancy.
We are certified psychologists in perinatal mental health and psychiatrist and reproductive neuroscientific that studies female hormones and pharmacological treatments for depression. We are concerned that many statements made in the meeting about the dangers of these medications contradict decades of evidence of research that shows that the use of antidepressants during pregnancy is low risk compared to the dangers of mental illnesses.
As doctors, we have front row seats for the maternal mental health crisis in the US mental illnesses, including suicide and overdose, are the main cause of maternal deaths. Like all medicines, SSRIs carry risks and benefits. But research shows that the benefits for pregnant patients exceed the risks of SSFS, as well as the risks of unrelated depression.
The panel did not approach the safety of the SSRIs after childbirth, but numerous studies show that taking ISRS antidepressants during breastfeeding is low risk, usually produces low to undetectable medications levels in babies.
Maternal brain health biology
Pregnancy and the months after childbirth are characterized by so many emotional, psychological and physical changes that the transition to motherhood has a specific name: matrescence. During motherhood, the brain changes rapidly as it prepares to efficiently care for a baby.
The ability to change within the brain is known as “plasticity.” The greatest plasticity during pregnancy and the postpartum period is what allows the maternal brain to be better tuned and carry out the tasks of motherhood. For example, research indicates that, during this period, the brain is prepared to respond to baby -related stimuli and improve the mother’s ability to regulate her emotions. These brain changes also act as a mental shock absorber against aging and long -term stress.
On the other hand, these rapid brain changes, driven by hormonal changes, can make people especially vulnerable to the risk of mental illnesses during and after pregnancy. For women who have a history of depression, the risk is even greater.
Clinical depression interferes with cerebral plasticity, so that the brain is “stuck” in patterns of negative thoughts, emotions and behaviors.
This leads to a deterioration of brain functions that are essential for motherhood. The new mothers with depression have a diminished brain activity in the regions responsible for motivation, the regulation of emotions and problem solving. They are often withdrawn or overprotectors with their babies, and fight with the implacable effort necessary for the tasks that arise with the raising of children, such as calming, feeding, stimulating, planning and anticipating the child’s needs.
Research shows that ISRs work promoting brain plasticity. This, in turn, allows people to perceive the world more positively, increase the experience of gratification as a mother and facilitate cognitive flexibility for problem solving.
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EVALUATION OF THE RISKS OF SSRS IN PREGNANCY
The prescription medications such as SSRIs are just one aspect of the treatment of pregnant women fighting mental illnesses. Evidence-based psychotherapy, such as cognitive-behavioral therapy, can also induce adaptive brain changes. But women with serious symptoms often require medications before being able to harvest the benefits of psychotherapy, and finding duly trained, accessible and affordable psychotherapists can be a challenge. So, sometimes, the SSRIs can be the most appropriate treatment option available.
Multiple studies have examined the effects of SSRs on the development fetus. Some data show a link between these medications and premature delivery, as well as low birth weight. However, depression during pregnancy is also related to these effects, which makes it difficult to unravel what is due to the medication and what is due to the disease.
The SSRIs are related to a condition called neonatal adaptation syndrome, in which babies are born nervous, irritable and with an abnormal muscle tone. Around a third of babies born of mothers who take it experience it. However, research shows that it is generally resolved in two weeks and has no implications for long -term health.
The panel convened by the FDA was largely focused on the potential risks of the use of SSRIs, and several people incorrectly stated that these medications cause autism in exposed young people, as well as birth defects. At least one panelist discussed clinical depression as a “normal” part of the “emotional” experience during pregnancy and after childbirth. This perpetuates a long history of women who are fired, ignored and not believed in medical care. It also rules out the rigorous evaluation and the criteria used by medical professionals to diagnose reproductive mental health disorders.
A summary of the fundamental studies on the SSRIs in the pregnancy carried out by the Women’s Health Center of the Massachusetts General Hospital analyzes how research has shown that the SSRIs are not associated with spontaneous abortions, birth defects or development conditions in children, including autistic spectrum disorder.
The risks of an unrelated mental illness
Clinical depression not treated in pregnancy has several known risks. As noted above, babies born to mothers with clinical depression have a higher risk of premature delivery and low birth weight.
It is also more likely that they require neonatal intensive care and have a greater risk of behavioral problems and cognitive impairment in childhood.
Women who are clinically depressed have a greater risk of developing preeclampsia, a condition that involves high blood pressure that, if it does not identify and treats quickly, can be fatal for both the mother and the fetus. Same worrying is the greatest risk of suicide in depression. Suicide represents about 8% of deaths during pregnancy and shortly after birth.
Compared to these very serious risks, the risks of using SSRs during pregnancy turn out to be minimal. Although women used to stop taking SSRs during pregnancy to avoid some of these risks, this is no longer recommended, since it exposes women to a high probability of relapse of depression. The American College of Obstetricians and Gynecologists recommend that all perinatal mental health treatments, including ISRS, continue to be available.
Many women are already reluctant to take antidepressants during pregnancy and, if given the option, tend to avoid it. From a psychological point of view, exposing its fetus for the side effects of antidepressant medications is one of the many common reasons why women in the US feel maternal guilt or shame. However, the available data suggest that such guilt is not justified.
Together, the best thing that can be done for pregnant women and their babies is not to avoid these medications when necessary, but take all possible measures to promote health: optimal prenatal care and the combination of medications with psychotherapy, as well as other evidence -based treatments, such as bright light therapy, proper exercise and nutrition.
The panel did not approach the most recent neuroscience behind depression, how antidepressants in the brain and the biological justification of why doctors use them first. Patients deserve education about what is happening in their brain and how a medicine like an SSRI could work to help.
Depression during pregnancy and in the months after childbirth is a barrier would be for the brain health of mothers. Irs are a way to promote healthy brain changes so that mothers can prosper both in the short and long term.
If the FDA, as a result of this recent panel, decides to place a black box warning on antidepressants in pregnancy, researchers like us already know for history what will happen. In 2004, the FDA placed a warning on antidepressants that described possible suicidal ideas and behaviors in young people.
In the following years, the prescription of antidepressants decreased, while the consequences of mental illnesses increased. And it is easy to imagine a similar pattern in pregnant women.
*Nicole Amoyal Pensak is a researcher for the management of the stress of the caregiver and clinical psychologist; Andrés Novick is an assistant professor of psychiatry both of the Anschutz Medical Campus of the University of Colorado.
This article was originally published in The Conversation/Reuters
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