FDA Committee Raises Concerns About Antidepressant Use During Pregnancy Risks for Mothers

On July 21, 2025, a meeting convened by the Food and Drug Administration (FDA) prompted discussions that cast doubt on the safety of antidepressant medications, specifically selective serotonin reuptake inhibitors (SSRIs), during pregnancy. The panel considered the possibility of incorporating a black box warning—indicating severe or potentially life-threatening risks—regarding the use of these drugs in pregnant women. Some panel members, known for their skepticism toward antidepressant safety, debated the true risks involved.

SSRIs, such as Prozac and Zoloft, are the most widely prescribed treatments for depression and are considered first-line options during pregnancy, with approximately 5-6% of pregnant women in North America using them. Despite these common practices, concerns about their safety in fetal development gained attention during the meeting.

Advocates and researchers, including psychologists and neuroscientists specializing in women's mental health, emphasized that extensive research over decades indicates that antidepressant use in pregnancy is generally low risk. The dangers associated with untreated maternal depression—such as preterm birth, low birth weight, and long-term emotional and behavioral issues—are often greater than the risks posed by medication. Additionally, maternal mental health crisis is a leading cause of maternal mortality in the U.S., with depression, suicide, and overdose being significant contributors.

The panel discussed adding a black box warning, as seen with other medications, to highlight potential fetal risks. However, many experts believe that such warnings could discourage women from using effective treatment, ultimately worsening health outcomes. Evidence shows that SSRIs can promote brain plasticity, aiding in emotional regulation and cognitive flexibility—beneficial effects especially critical during motherhood.

Research also indicates that antidepressants are safe during breastfeeding, usually resulting in minimal drug levels in infants, contrary to some critics’ claims. The debate underscores the importance of balanced, evidence-based approaches to treating depression during pregnancy. Untreated depression carries tangible risks such as preterm delivery, neonatal complications, behavioral problems, and increased risk of preeclampsia and maternal suicide.

Historically, placing warnings on medications has led to decreased prescriptions and increased adverse outcomes due to untreated mental health conditions. Experts warn that similar consequences could follow if the FDA mandates stricter warnings on antidepressants during pregnancy.

In sum, the evidence supports continued access to SSRIs for pregnant women in need, combined with comprehensive prenatal care and support. Patients should be educated about the benefits of medication in managing depression and supporting maternal brain health, rather than the misconceptions propagated in such panels.