Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (11): 1286-1289.
DOI: 10.19803/j.1672-8629.20230074

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Two cases of fetal malformation after exposure to low dose warfarin sodium tablets in early pregnancy

YANG Caihua1, YANG Longna2, LI Xiaobo3,*   

  1. 1Clinical Pharmacy Center, Nanfang Hospital,Southern Medical University, Guangzhou Guangdong 510515, China;
    2Nursing Department of Zhuhai Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Zhuhai Guangdong 519020, China;
    3Department of Pharmacy, Zhuhai Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Zhuhai Guangdong 519020, China
  • Received:2023-02-13 Online:2023-11-15 Published:2023-11-13

Abstract: Objective To investigate the influencing factors and pharmacogenetic effects of fetal malformation caused by maternal exposure to low-dose warfarin sodium tablets during early pregnancy. Methods Two cases of fetal cleft lips and palates as well as short nasal bone development due to exposure to low-dose warfarin sodium tablets(<5 mg·d-1) during early pregnancy for anticoagulation after mechanical valve replacement were reported. The possible drug correlations and teratogenic molecular mechanism between fetal malformation and low-dose warfarin were discussed based on related literature. Results and Conclusion In Chinese populations, low-dose warfarin exposure(<5 mg·d-1) in early pregnancy can increase the risk of fetal oral-facial malformation, and its teratogenic mechanism may be correlated with the maternal warfarin dose, exposure time window and individual differences. Literature suggests that inter-individual CYP2C9, VKORC1 gene polymorphisms and AYL Sulfatase E gene mutations may also play a key role, which deserves clinical attention.

Key words: warfarin sodium tablets, pregnancy, low-dose, cleft lip and palate, nasal bone hypoplasia, adverse drug reaction

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