Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (9): 869-871.
DOI: 10.19803/j.1672-8629.2021.09.15

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Analysis of Risks of Longbishu Preparation

PANG Yu1, ZHU Lan1, WANG Tao1, YU Hongli1, SHAO Bo1, LIU Bo2,*   

  1. 1Center for Drug Reevaluation, Key Laboratory for Research and Evaluation of Pharmacovigilance, NMPA, Beijing 100022, China;
    2China Institute for Food and Drug Control, Beijing 102629, China
  • Received:2021-01-07 Online:2021-09-15 Published:2021-09-18

Abstract: Objective To analyze the risk of Longbishu preparations, especially the liver injury risk, in order to provide reference for clinical safe drug use. Methods Individual adverse drug reaction cases in China retrieved from the adverse drug reaction database and domestic literature were analyzed. Results Longbishu preparations could possibly cause nausea, vomiting, abdominal pain, diarrhea, stomach discomfort, dizziness, thirst, fatigue, liver dysfunction and other adverse reactions. Conclusion The monitoring of clinical use of Longbishu preparations should be upgraded. Marketing authorization holders are expected to update the drug label information and promote the safe use of medicineto ensure the safety of drug users.

Key words: Longbishu, labeling, liver injury, adverse reaction, safety

CLC Number: