FDA Panel Sparks Controversy Over Safety of SSRIs in Pregnancy

A recent expert panel organized by the US Food and Drug Administration (FDA) has cast doubt on the safety of Selective Serotonin Reuptake Inhibitors (SSRIs) during pregnancy, sparking criticism from prominent medical societies. However, experts argue that the claims made by the panel are largely based on misinterpreted or misrepresented evidence.

Nearly one in five pregnant women and new moms suffer from anxiety and depression, with 6-8% prescribed SSRIs to treat these conditions. The FDA panel’s comments have raised concerns among healthcare providers, who note that untreated depression during pregnancy poses significant health risks, including suicide, preterm birth, and low birth weight.

However, several medical societies, including the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine, have spoken out against the panel’s claims, stating that they misrepresented evidence and spread misinformation. ACOG has emphasized that robust evidence shows SSRIs to be safe during pregnancy, with no increased risk of birth defects.

Critics of the FDA panel point out that some studies cited as evidence were conducted on non-pregnant populations or had methodological flaws. Additionally, studies comparing pregnant women on SSRIs with those not taking the medication have found no significant risks associated with SSRI use.

Experts emphasize the importance of addressing untreated perinatal depression, which can lead to poor prenatal care attendance, substance abuse during pregnancy, and increased risk of complications such as pre-eclampsia and cesarean delivery. While SSRIs are a valuable treatment option for some pregnant and postpartum women, they should not be used as the only solution.

The debate highlights the need for clear communication and accurate information about SSRI safety during pregnancy. As one expert noted, “We have a lot of tools in our toolbox” to treat depression and anxiety in pregnant and postpartum women, including psychotherapy, psychosocial treatments, exercise, yoga, and meditation.

Source: https://www.npr.org/sections/shots-health-news/2025/08/01/nx-s1-5487710/fda-panel-ssri-antidepressants-pregnancy-perinatal