Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (9): 553-556.

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Post-marketing Safety Literature Analysis and Risk Control Recommendations of Shuxuening Injection

YANG Le1, WANG Yan-chun2 ,DU Xiao-xi1, REN Jing-tian1 ,Song Hai-bo1, LIU Xi-dan3*   

  1. 1.Center for Drug Reevaluation, CFDA, Beijing 100045, China;
    2.Fushun Institute for Food and Drug Controlc Fushun Center for ADR Monitoring, Liaoning Fushun 113006, China;
    3.Urumqi Food and Drug Administration, Xinjiang Urumqi 830002, China
  • Received:2013-04-15 Revised:2016-03-09 Online:2013-09-08 Published:2016-03-09

Abstract: Shuxuening injection is the ginkgo preparation which is widely used in clinic. By retrospective study on shuxuening injection post-marketing safety status in the literature at home and abroad, it is found that the main adverse reactions of allergic reactions with the characteristics of immediate hypersensitivity, alone or in combination may cause risk. Serious adverse reactions mainly involved anaphylactoid reaction, allergic shock, respiratory system damage with difficult breathing, cardiovascular system damage with chest tightness and palpitation. There are very rare literatures reported bleeding. We put forward risk control measures in accordance with the drug itself characteristics, and suggestions for safe and rational use of the drug.

Key words: Shuxuening injection, literature analysis, risk control, recommendation

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