Sodium oxybate and other drugs flagged for perinatal depression risk in pharmacovigilance analysis

A retrospective pharmacovigilance study analyzed the FDA Adverse Event Reporting System from Q1 2004 to Q2 2025 to evaluate drug-related perinatal depression risk. The population included women during pregnancy and the postpartum period. The analysis focused on the use of specific drugs and demographic factors, including sodium oxybate, levonorgestrel, ethinylestradiol/etonogestrel, lurasidone, age under 26 years, and weight exceeding 74 kg.

The study identified 28 drugs with positive signals for an association with perinatal depression. Independent risk factors for drug-related perinatal depression were age under 26 years, weight exceeding 74 kg, and use of sodium oxybate, levonorgestrel, ethinylestradiol/etonogestrel, or lurasidone. The model's discriminatory performance was reported as an ROC-AUC of 0.907.

Safety and tolerability data, including adverse events, serious adverse events, and discontinuations, were not reported in this analysis. The study design does not allow for the assessment of causality, and the findings may be subject to reporting biases inherent in spontaneous reporting systems. The lack of a defined comparator group and the absence of adjusted effect measures limit interpretability.

While these data offer valuable insights for pharmacovigilance and clinical medication management, they should not be used to guide treatment decisions. Clinicians should interpret these signals cautiously and consider them as part of a broader risk assessment when evaluating medications for perinatal depression.