The FDA is reviewing black-box warnings for SSRIs in pregnancy.
The FDA is reviewing black-box warnings for SSRIs in pregnancy. Long-term studies show no increased birth defect risk, but untreated depression can lead to preterm birth, high blood pressure, and maternal suicide.
The U.S. Food and Drug Administration (FDA) is evaluating whether to introduce a black-box warning for the use of antidepressants during pregnancy, a measure that has sparked discussion among healthcare professionals. Black-box warnings represent the agency’s strongest safety advisories, typically reserved for drugs with well-established serious risks. Some researchers argue that such warnings enhance transparency, while many clinicians caution that they could inadvertently discourage pregnant individuals from seeking necessary mental health care.
Recently, FDA Commissioner Marty Makary convened a panel to review the use of selective serotonin reuptake inhibitors (SSRIs), which are commonly prescribed for depression and anxiety. Panelists discussed potential effects on fetal development, including impacts on brain and cardiac formation, and possible associations with conditions such as postpartum hemorrhage and pulmonary hypertension in newborns. Epidemiologist Anick Bérard highlighted studies suggesting an increased likelihood of miscarriage and low birth weight associated with certain SSRIs, including paroxetine and fluoxetine.
However, leading medical organizations, including the American College of Obstetricians and Gynecologists (ACOG), have raised concerns that the discussion presented a one-sided view. Experts emphasize that untreated mood disorders during pregnancy can result in serious complications, such as preterm birth, hypertensive disorders, low birth weight, and maternal suicide. Balancing the communication of potential risks with the importance of effective mental health treatment is essential to support both maternal and fetal well-being.
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Depression affects approximately 20 % of pregnant individuals, and a similar proportion experience significant anxiety. Roughly 8 % of these individuals rely on SSRIs to manage symptoms. While non-pharmacological therapy is often recommended for mild cases, medication may be necessary for moderate to severe conditions. Clinical decisions are guided by careful risk–benefit analyses, aiming to safeguard both maternal and infant health.
Long-term observational studies provide some reassurance regarding SSRI safety. Over the past three decades, large-scale research indicates that SSRIs do not substantially increase the baseline risk of congenital malformations, which generally occurs in 3–5 % of pregnancies. Some studies suggest elevated risks of miscarriage or lower birth weight, but methodological limitations—including inappropriate comparison groups—affect the reliability of these findings. Experts advocate for more rigorous studies comparing outcomes between pregnant individuals with depression who use SSRIs and those with untreated depression.
The FDA has not yet announced whether a black-box warning will be implemented. Clinicians caution that overly restrictive labeling could reduce patient confidence, potentially deterring treatment for conditions that carry their own measurable risks. Maintaining a careful balance between informed patient choice and ongoing access to effective mental health care remains a priority for healthcare providers.
Source: Nexstar Media
