Divergent safety profiles of TNF inhibitors in pregnancy: a comprehensive pharmacovigilance analysis of the FAERS database - PubMed
4 hours ago
- #Pharmacovigilance
- #TNF inhibitors
- #Pregnancy safety
- The study analyzes 7,022 pregnancy exposure reports from the FAERS database (2004-2025) to explore safety signals of five TNF inhibitors (TNFis).
- A notable safety signal for lactation impairment was detected for four TNFis, with reporting odds ratios ranging from 21.3 to 130.3.
- Temporal risk patterns differed: adalimumab and etanercept (high placental transfer) showed increasing reporting rates over time, while certolizumab pegol (minimal transfer) exhibited a constant risk pattern.
- The findings suggest potential heterogeneity in TNFi safety profiles during pregnancy and lactation, linking molecular structure to adverse event patterns, but require cautious interpretation due to reporting biases.
- The study concludes by generating hypotheses for future validation through prospective studies to support individualized risk assessment.