#5-81E. Evaluating Belimumab Safety in Lupus Pregnancy: Real-World Signals from FAERS (Ther Adv Drug Saf, 2026)

How safe is belimumab during pregnancy for women with systemic lupus erythematosus? A real-world pharmacovigilance study using FAERS data demonstrates that belimumab exposure is not associated with an increased risk of stillbirth, preterm birth, or major congenital malformations. However, safety signals emerged for abortion, gestational hypertension, and neonatal respiratory distress, though these may partially reflect underlying SLE activity rather than direct drug toxicity. These findings reassure clinicians regarding major structural defects while highlighting the necessity for careful risk-benefit evaluation and vigilant neonatal monitoring during pregnancy management.

Citation: Yujie Lin, Jing Yao. Safety of belimumab during pregnancy: associations with maternal and fetal or newborn adverse outcomes based on FAERS data. Therapeutic Advances in Drug Safety. 2026. DOI: 10.1177/20420986261460168

URL: https://doi.org/10.1177/20420986261460168

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