Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (7): 791-794.
DOI: 10.19803/j.1672-8629.20230067

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Risks to safety of vitamin B6 injection

YANG Le, XIA Dongsheng, WANG Tao   

  1. Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China
  • Received:2023-02-13 Online:2023-07-15 Published:2023-07-14

Abstract: Objective To analyze the risks to safety posed by vitamin B6 injection in China in order to provide reference for clinical rational drug use. Methods The individual cases of adverse drug reactions retrieved from China adverse drug reaction database (from January 1, 2004 to June 30, 2019) and WHO Vigilyze (from inception to January 31, 2023), and other databases (from inception to December 31, 2020) were analyzed. Results The risk posed by vitamin B6 injection, general disorders, and related cutaneous and gastrointestinal system damage deserved more attention. Conclusion Drug marketing authorization holders should reinforce the safety monitoring of vitamin B6 injection, update the drug labeling in a timely manner and promote the rational use of medicines.

Key words: vitamin B6, drug adverse reaction, safety, risk, regulatory measures, instruction, drug marketing authorization holders

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