A panel convened by the agency was invited at a meeting held by the Food and Drug Administration on July 21, 2025, on the safety of antidepressants called selective serotonin reuptake inhibitors (SSRIs) during pregnancy.
Members of the panel discussed the addition of so-called black box warnings to drugs, which agencies use to indicate severe or life-threatening side effects. Some of the panelists present had a history of expressing deep skepticism about antidepressants.
SSRIS contains drugs such as Prozac and Zoloft, and is the most commonly used drug for the treatment of clinical depression. They are considered first-line drugs to treat depression during pregnancy, with about 5% to 6% of North American women taking SSRIs during pregnancy.
You might like it
We are certified psychologists in perinatal mental health, and germ psychiatrist and neuroscientists studying female hormones and drug treatments for depression. We are concerned that many of the claims made at conferences on the risks of these drugs are inconsistent with decades of research evidence showing that antidepressant use during pregnancy is at a lower risk when compared to risk of mental illness.
As clinicians, we have front row seats for maternal mental health crisis in US mental illness, such as suicide and overdose, but are the main causes of maternal deaths. Like all drugs, SSRIs carry both risks and benefits. However, studies have shown that benefits for pregnant patients outweigh the risk of SSRI and untreated depression.
Although the panel did not address the safety of postpartum SSRIs, many studies have found that taking SSRI antidepressants during breastfeeding is low risk and can usually result in lower drug levels in babies.
Related: “Love Hormone” Oxytocin may pause pregnancy, animal studies find
Biology of maternal brain health
The transition to motherhood comes with a specific name, as pregnancy and months after birth are characterized by so many emotional, psychological and physical changes. During mattress sense, the brain changes rapidly as it prepares to efficiently handle care for your baby.
The ability to change in the brain is known as “plasticity.” Improved plasticity during pregnancy and postpartum periods allow the maternal brain to become more accustomed to and performed maternal tasks. For example, research shows that during this period, the brain is primed to respond to baby-related stimuli and improve the maternal ability to regulate emotions. These brain shifts also serve as mental buffers for aging and stress in the long term.
Conversely, these rapid brain changes fuelled by hormonal changes can make them particularly vulnerable to the risk of mental illness during and after pregnancy. For women with past history of depression, the risk is even greater.
Clinical depression interferes with brain plasticity, causing the brain to “stuck” in negative patterns of thought, emotion and behavior.
This leads to impaired brain function, which is essential for motherhood. New mothers with depression are reducing local brain activity that can motivate, regulate emotions, and problem-solving. They often withdraw or overprotect infants, and fight against the relentless efforts required for the tasks that arise in parenting, such as healing, feeding, stimulating, planning, and prediction.
Research shows that SSRIs work by promoting brain plasticity. This allows individuals to perceive the world more positively, enhance experiences of maternal satisfaction and promote cognitive flexibility in problem-solving.
Assessment of the risk of SSRI during pregnancy
Prescription drugs like SSRIs are just one aspect of treatment for pregnant women suffering from mental illness. Evidence-based psychotherapy, such as cognitive behavioral therapy, can also induce adaptive brain changes. However, women with severe symptoms often need medication before they can enjoy the benefits of psychotherapy, and finding a properly trained, accessible and affordable psychotherapist can be challenging. Therefore, SSRIs may be the most appropriate treatment option available.
Several studies have investigated the effects of SSRI on developing fetuses. Some data show links between these drugs and preterm births and low birth weight. However, depression during pregnancy is also associated with these effects, so it is difficult to resolve drug-induced and disease-induced disease.
SSRIs are linked to a condition called neonatal indication syndrome, where infants are unstable, irritated and born with abnormal muscle tension. Approximately one-third of infants born to mothers taking SSRIs experience it. However, research shows that it usually resolves within two weeks and has no long-term health effects.
A panel held by the FDA focuses on the potential risks of SSRI use, falsely claiming that these drugs cause autism and birth defects in exposed youths. At least one panelist discussed clinical depression as the “normal” part of “emotional” experiences during and after birth. This perpetuates a long history of women being rejected, ignored and not trusted in healthcare. They also discount strict assessments and criteria used by healthcare professionals to diagnose reproductive mental health disorders.
A summary of a pivotal study of SSRIs during pregnancy by the Massachusetts Center for Women’s Health explains how research shows that SSRIs are not associated with abortion, birth defects, or developmental status in children, including autism spectrum disorders.
Risk of untreated mental illness
There are several known risks for untreated clinical depression during pregnancy. As mentioned above, babies born to mothers with clinical depression are at higher risk of premature birth and low birth weight.
They are also likely to require intensive care for the newborn, increasing the risk of childhood behavioral problems and cognitive impairment.
Women who are clinically depressed are at a higher risk of developing pre-lammedia. This is a condition involving hypertension, which is fatal for both the mother and the fetus, if not rapidly identified and treated. Just as concerning, there is an increased risk of suicide in depression. Suicide accounts for approximately 8% of deaths during pregnancy and immediately after birth.
Compared to these very serious risks, the risk of using SSRIs during pregnancy was found to be minimal. Women were encouraged to stop taking SSRIs during pregnancy to avoid some of these risks, but this is no longer recommended. This is to increase the likelihood that women will have a recurrence of depression. The US University of Obstetrics and Gynecology recommends that all perinatal mental health treatments, including SSRIs, remain available.
Many women are already reluctant to take antidepressants during pregnancy and are given a choice, and they tend to avoid it. From a psychological perspective, exposing the fetus to the side effects of antidepressants is one of many common reasons why women in the US feel guilt and shame in their mothers. However, the available data suggests that such guilt is not guaranteed.
In summary, the best thing you can do for a pregnant woman and her baby is not to avoid prescribing these medications when necessary, but to take all possible measures to promote health: combinations of optimal prenatal care and psychotherapy, and other evidence-based treatments such as bright light therapy, exercise, and proper nutrition.
The panel has failed to address the latest neuroscience behind depression, how antidepressants work in the brain, and why doctors use them in the first place. Patients deserve to be educated about what is happening in the brain and how medications like SSRIs can help.
Depression during pregnancy and several months after birth is a serious barrier to maternal brain health. SSRI is one way to promote healthy brain changes, allowing mothers to thrive for both the short and long term.
Researchers like us already know what will happen from history if the FDA decides to put a black box warning on antidepressants during pregnancy as a result of this recent panel. In 2004, the FDA issued a warning against antidepressants that explain the potential suicidal ideation and behavior in young people.
The following year, psychiatric illness outcomes increased, while antidepressant pressing decreased. And it’s easy to imagine a similar pattern for pregnant women.
This edited article will be republished from the conversation under a Creative Commons license. Please read the original article.
Source link
