Drug-associated postpartum hemorrhage: a comprehensive disproportionality analysis based on the FAERS database

Area of Science:

• Pharmacovigilance
• Obstetrics
• Drug Safety

Background:

• Postpartum hemorrhage (PPH) is a critical obstetric complication with significant maternal morbidity and mortality.
• Identifying iatrogenic causes of PPH is crucial for improving patient outcomes and developing targeted prevention strategies.

Purpose of the Study:

• To identify drugs associated with PPH using the FDA Adverse Event Reporting System (FAERS) database.
• To provide scientific evidence for the targeted prevention of drug-related PPH risk factors.
• To analyze the temporal occurrence of adverse drug events (ADEs) related to PPH.

Main Methods:

• Disproportionality analysis of FAERS data from 2004Q1 to 2025Q1.
• Utilized statistical methods including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayes Geometric Mean (EBGM) for signal detection.
• Identified drug-event combinations with statistically significant associations with PPH.

Main Results:

• A total of 1078 reports of PPH-related ADEs were analyzed, with 97.96% resulting in serious consequences.
• 32 drugs across 14 systems met the study's signal detection criteria.
• Oxytocin, dinoprostone, and misoprostol were the top three drugs associated with PPH, all commonly used in labor induction or PPH management.
• Significant PPH events were observed within the first month and up to 360 days after medication administration, indicating long-term risks.

Conclusions:

• This study successfully identified and ranked drugs associated with PPH, underscoring the importance of pharmacovigilance.
• The findings emphasize the need for personalized monitoring strategies during the perinatal period.
• Long-term risks of PPH associated with chronic disease medications used during pregnancy require further attention and research.