Proton Pump Inhibitors Linked to Adverse Pregnancy Outcomes

Strategic Insights -

A new study published in the International Journal of Clinical Pharmacy has detected potential links between the use of proton pump inhibitors (PPIs) during pregnancy and reported adverse events, including premature labor, low birth weight, and prenatal complications. The research analyzed data from the US FDA Adverse Event Reporting System (FAERS) from 2004 to 2025 and identified 1,099 pregnancy-related reports among 625,127 adverse event reports listing PPIs as primary suspect drugs.

Key Takeaways:

  • The study found that omeprazole, a widely prescribed PPI, showed notable signals of postpartum hemorrhage, fetal growth restriction, and pre-eclampsia when compared to other drugs in the database.
  • Pantoprazole, another commonly used PPI, showed consistent risk signal trends, including premature labor, low birth weight, and morning sickness.
  • The associations between PPI use and adverse pregnancy outcomes were observed to be drug-specific, suggesting that certain PPIs may be more likely to be associated with specific adverse events.
  • The study's findings should be regarded as exploratory and hypothesis-generating, warranting cautious interpretation and confirmation through rigorously designed epidemiological and clinical studies.

Statistics:

  • 625,127 adverse event reports were retrieved from the FAERS database, among which 1,099 were pregnancy-related reports.
  • Omeprazole was associated with notable signals of postpartum hemorrhage (ROR: 3.14, 95% CI 1.63-6.04; E(IC): 1.36, IC025:0.45) and fetal growth restriction (ROR: 2.14, 95% CI 1.52-3.01; E(IC): 1.046, IC025:0.55).
  • Pantoprazole showed consistent risk signal trends, such as premature labor (ROR: 1.48, 95% CI 1.26-1.74; E(IC): 0.56, IC025:0.32) and low birth weight babies (ROR: 2.08, 95% CI 1.56-2.76; E(IC): 1.02, IC025:0.6).

Sources:

  • International Journal of Clinical Pharmacy, 2025 (Comparative evaluation of pregnancy-related adverse events associated with proton pump inhibitors using the FDA adverse event reporting system database)
  • Department of Pharmacy, People's Hospital of Chongqing Liangjiang New Area, Chongqing, 401121, People's Republic of China (Contact: Yuye Ran)
  • Springer, Van Godewijckstraat 30, 3311 Gz Dordrecht, Netherlands (Publisher contact information)