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<p>Postpartum hemorrhage (PPH) is a life-threatening obstetric complication. We aimed to identify the drugs that associated with PPH based on the FDA Adverse Event Reporting System (FAERS) data, providing scientific evidence for targeted prevention of drug-related PPH risk factors. Data from 2004Q1 to 2025Q1 were extracted from FAERS, and disproportionality analysis was performed to identify potential drug signals. The Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network of information components (IC), and Empirical Bayes Geometric Mean (EBGM) were employed to identify drug-event combinations associated with PPH with signals higher than expected, and to analyze the occurrence time of adverse drug events (ADEs). A total of 1078 reports with target ADE were obtained, and 97.96% of them resulted in serious consequences. A total of 246 primary suspected drugs were identified, among which, 32 drugs across 14 systems met the signal detection requirements of this study. In terms of the number of cases, the top three drugs that induce PPH were oxytocin (ROR [95% CI]: 1985.51 [1650.23–2388.91]), dinoprostone (ROR [95% CI]: 751.23 [549.82–1026.42]), and misoprostol (ROR [95% CI]: 193.58 [140.47–266.76]). They all belong to genito urinary system and sex hormones and are commonly used in clinical settings for labor induction or PPH. More than half of the cases (<i>n</i> = 224, 59.26%) occurred within the first month after medication administration, and surprisingly, approximately one-fifth of the cases occurred 360&#xa0;days after medication administration (<i>n</i> = 80, 21.16%), suggesting that the long-term risk of PPH cannot be ignored. This study identified and ranked drugs associated with PPH and analyzed the occurrence time of ADEs. We emphasized the need for personalized monitoring strategies during the perinatal period and highlighted the long-term risks of PPH caused by the use of chronic disease drugs during pregnancy.</p>

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

  • 期刊论文

  • 发表日期：

    2025年9月8日

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  • Yongjin Xie,
  • Jintuo Zhou,
  • Yingling Xie,
  • Yanting Zhu

摘要

Postpartum hemorrhage (PPH) is a life-threatening obstetric complication. We aimed to identify the drugs that associated with PPH based on the FDA Adverse Event Reporting System (FAERS) data, providing scientific evidence for targeted prevention of drug-related PPH risk factors. Data from 2004Q1 to 2025Q1 were extracted from FAERS, and disproportionality analysis was performed to identify potential drug signals. The Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network of information components (IC), and Empirical Bayes Geometric Mean (EBGM) were employed to identify drug-event combinations associated with PPH with signals higher than expected, and to analyze the occurrence time of adverse drug events (ADEs). A total of 1078 reports with target ADE were obtained, and 97.96% of them resulted in serious consequences. A total of 246 primary suspected drugs were identified, among which, 32 drugs across 14 systems met the signal detection requirements of this study. In terms of the number of cases, the top three drugs that induce PPH were oxytocin (ROR [95% CI]: 1985.51 [1650.23–2388.91]), dinoprostone (ROR [95% CI]: 751.23 [549.82–1026.42]), and misoprostol (ROR [95% CI]: 193.58 [140.47–266.76]). They all belong to genito urinary system and sex hormones and are commonly used in clinical settings for labor induction or PPH. More than half of the cases (n = 224, 59.26%) occurred within the first month after medication administration, and surprisingly, approximately one-fifth of the cases occurred 360 days after medication administration (n = 80, 21.16%), suggesting that the long-term risk of PPH cannot be ignored. This study identified and ranked drugs associated with PPH and analyzed the occurrence time of ADEs. We emphasized the need for personalized monitoring strategies during the perinatal period and highlighted the long-term risks of PPH caused by the use of chronic disease drugs during pregnancy.