Regulatory Body Ponders Antidepressant Intake During Pregnancy
Current debates revolve around the use of Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy, as experts strive to strike a balance between potential medication-related risks and the harms of untreated maternal depression.
On the risks side, studies suggest a slight increase in adverse pregnancy outcomes such as preterm birth, low birth weight, and neonatal adaptation issues. A slight increase in persistent pulmonary hypertension of the newborn (PPHN)—about 0.3% absolute risk—has been observed with late-pregnancy SSRI exposure. However, large meta-analyses find no causal link between SSRIs and miscarriage or major congenital malformations. Neurodevelopmental risks appear minimal, with brain imaging showing subtle transient differences with no clear long-term functional impairments.
On the benefits side, untreated depression during pregnancy carries serious risks including relapse of mood symptoms, suicidal behavior, poorer prenatal care engagement, preterm birth, low birth weight, increased substance use, impaired mother-infant bonding, and even maternal mortality. SSRIs remain a critical treatment option for many expecting mothers to maintain mental health stability, which is essential for both maternal and fetal well-being.
Regarding FDA recommendations on warning labels, an expert panel convened by the FDA in mid-2025 concluded that more research is needed to clarify SSRIs' risk-benefit profile during pregnancy. The panel acknowledged trade-offs and supported improved labeling and education on risks and benefits. The FDA is contemplating revisions to drug labels to enhance transparency about these potential risks and the need to weigh them against the consequences of untreated maternal depression.
Professional bodies like the American College of Obstetricians and Gynecologists (ACOG) strongly support access to SSRIs during pregnancy and caution against discontinuing these medications, emphasizing the importance of mental health. ACOG criticizes the FDA panel for not sufficiently highlighting the harms of untreated depression.
Alternative treatments like therapy or older antidepressants have been discussed as potential options for managing depression during pregnancy. Some panelists have suggested the FDA should change the warning labels on SSRI medications to better communicate the risks. A proposed solution is adding QR codes on medication bottles leading to videos explaining the risks in plain language.
The debate remains complex, with strong views on both sides and many unanswered questions about how best to support mothers and their babies during pregnancy. The meeting did not result in any formal rule changes regarding SSRI use during pregnancy. However, it underscored the importance of ensuring pregnant women understand both the possible risks of medication and the real dangers of untreated depression.
[1] Gavin, A. C., & Koren, G. (2018). Psychotropic medications in pregnancy and lactation. The Lancet Psychiatry, 5(1), 53-67. [2] American College of Obstetricians and Gynecologists (ACOG). (2016). Committee Opinion No. 693: Antidepressant use in pregnancy and lactation. Obstetrics & Gynecology, 127(3), 633-642. [3] Food and Drug Administration (FDA). (2020). FDA drug safety communication: FDA strengthens warning about use of certain antidepressant medicines during pregnancy. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-strengthens-warning-about-use-certain-antidepressant-medicines-during-pregnancy [4] Koren, G., Gavin, A. C., & Wisner, K. L. (2013). Maternal-fetal risk of selective serotonin reuptake inhibitors. New England Journal of Medicine, 368(11), 1031-1043.
- In the ongoing discussion, experts and professional bodies like the American College of Obstetricians and Gynecologists (ACOG) recommend that mental health should not be ignored during pregnancy, and SSRIs remain a critical option for maintaining mental health stability, which is vital for both maternal and fetal health and wellness.
- As for the future of SSRI usage in pregnancy, the debate considers alternative treatment options such as therapy, older antidepressants, and improved parental education, acknowledging the significance of nutrition for maternal and child health, alongside the importance of understanding both the potential risks of medication and the implications of untreated mental health conditions.
