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Reframing FDA guidance on SSRI use in pregnancy: a rights-centered perspective


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Abstract

Perinatal mood and anxiety disorders affect up to one in four pregnant and postpartum individuals, representing one of the most common complications of the perinatal period. Untreated illness carries serious risks including preterm birth, impaired bonding, neurodevelopmental vulnerability, and suicide—a leading cause of maternal death in high-income countries. Conversely, selective serotonin reuptake inhibitors (SSRIs), when clinically indicated, have not been consistently associated with teratogenic or long-term neurodevelopmental risks. Large-scale studies such as Huybrechts et al. (2014), Furu et al. (2015), and Brown et al. (2017) confirm that most apparent associations disappear after accounting for confounding factors. Recent reviews (Wisner et al., 2020; Pawluski & Oberlander, 2025) highlight the importance of contextualizing these risks. Importantly, SSRIs may even confer developmental resilience in children of mothers with depression.
This viewpoint argues for reframing FDA guidance within a dual-risk, equity-oriented framework, grounded in international guidelines (ACOG, 2023; 2025; NICE, 2020; CANMAT, 2016) and regional perspectives such as the Latin American Perinatal Mental Health Network (2025). A rights-centered approach is advocated, one that respects women’s autonomy, ensures equitable access to treatment, and promotes evidence-based decision-making globally. Ultimately, reframing FDA guidance through a dual-risk, rights-based lens is not only a matter of clinical nuance but also of public health significance, as regulatory messaging profoundly shapes treatment adherence, health equity, and maternal–infant outcomes worldwide.

Keywords

postpartum, selective serotonin reuptake inhibitors, perinatal mental health, pregnancy

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