By Janet Choi, MD, MSCP, Chief Medical Officer
In the past few weeks, two important FDA panels met and took very different approaches to women’s health issues. These meetings sparked a larger conversation about how medical treatments for women are evaluated and discussed.
Panel 1: Menopausal Hormone Therapy (MHT)
On July 17, 2025, the FDA convened an expert panel during which participants called for removing strict warning labels (known as black box warnings) on certain forms of MHT, citing that many women may shy away from using MHT to treat vasomotor symptoms and prevent bone loss due to fear instilled by the labelling.
While MHT can be effective in treating vasomotor symptoms as well as preventing bone loss, it does carry a small increased risk for blood clot and stroke—though this risk does not appear to be as great for those using vaginal estrogen (which is often prescribed to treat genitourinary syndrome of menopause). It’s important that prescribing physicians consider each patient’s history, conditions, and needs in tandem with the available research on all forms of MHT and their proven benefits and risks.
Panel 2: Antidepressants During Pregnancy
Just a few days later, on July 21, an FDA panel, which met on selective serotonin reuptake inhibitors (SSRIs) and Pregnancy, took a different approach. Its members argued for adding warnings about use of SSRIs—oral drugs that are frequently used to treat depression and anxiety—during pregnancy.
This recommendation is concerning for the more than 20% of pregnant women who are affected by mental health disorders. Mental health remains the leading cause of death in pregnant women and new mothers in the U.S. For most pregnant women with anxiety and depression, the benefits of stabilizing their disorders far outweigh the risks of SSRIs, and the medical community’s response was swift and critical to that end. The American College of Obstetricians and Gynecologists (ACOG) emphasized that “robust evidence shows SSRIs are safe in pregnancy” while “untreated depression can put patients at risk for substance use, preterm birth, preeclampsia, and limited medical care engagement.”
What This Means
Both hormone therapy during menopause and antidepressants during pregnancy carry manageable risks, but also significant benefits. Women deserve evidence-based, balanced assessments that consider both their wellbeing and potential risks.
It’s critical to demand comprehensive risk-benefit discussions in shared decision-making about treatment. The science supports thoughtful, individualized care that prioritizes what’s truly best for each person’s health.