Safety analysis of fondaparinux in pregnancy based on case report literature
- VernacularTitle:基于病例报告文献的妊娠期使用磺达肝癸钠安全性分析
- Author:
Yin WANG
1
,
2
;
Fengqun CAI
1
,
2
;
Fengjiao KANG
1
,
2
;
Liuyun WU
1
,
2
;
Hulin WANG
1
,
2
;
Lizhu HAN
2
;
Qinan YIN
2
;
Yong YANG
2
;
Yuan BIAN
2
Author Information
1. School of Medicine，University of Electronic Science and Technology of China，Chengdu 610054，China
2. Personalized Drug Therapy Key Laboratory of Sichuan Province/Dept. of Pharmacy，Sichuan Academy of Medical Sciences·Sichuan Provincial People’s Hospital （Affiliated Hospital of University of Electronic Science and Technology of China），Chengdu 610072，China
- Publication Type:Journal Article
- Keywords:
fondaparinux;
pregnancy;
safety evaluation
- From:
China Pharmacy
2025;36(9):1099-1104
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To evaluate the safety of fondaparinux in pregnancy and provide reference for its rational clinical application. METHODS A search was conducted in databases including CNKI， Wanfang， PubMed， Embase， and Elsevier （the search time was from the construction of the database to December 17， 2024） to collect case report literature on fondaparinux use during pregnancy. Patient demographic information， fondaparinux use during pregnancy， concomitant medications， clinical manifestations， and treatment details were extracted for descriptive statistical analysis. RESULTS A total of 17 case reports regarding the use of fondaparinux during pregnancy were collected， involving 42 patients from 11 countries and 47 pregnancy records. Among these， 20 cases involved the use of fondaparinux for the prevention of pregnancy-related venous thromboembolism （VTE）， while 27 cases were fondaparinux treatment due to related conditions. A total of 29 occurrences of the patients were treated with fondaparinux due to a （family） history of VTE. Nine occurrences of complicated pregnancies were reported， and 35 patients had records of comorbidities or relevant medical histories. The adverse events that occurred during pregnancy with the use of fondaparinux include postpartum hemorrhage （7 cases） and excessive anticoagulation caused by inappropriate dosage （1 case）. Among the 7 cases of postpartum hemorrhage， 3 cases had a blood loss of no less than 1 000 mL （including 2 cases with uterine atony）， 3 cases had a drug discontinuation time of ≤12 h. CONCLUSIONS Based on the existing literature， the safety of fondaparinux during pregnancy is generally manageable， with the main adverse event being postpartum hemorrhage. The dosage， interval between discontinuation，comorbidities/medical history， and concomitant medications of fondaparinux may be the main causes of its adverse events.
