Risk Signals of Innovative Antineoplastic Drug Chidamide Tablets

doi:10.19803/j.1672-8629.2019.10.09

Abstract

Abstract: Objective To analyze the risk signals of chidamide tablets in China in order to provide reference for clinical rational use of this drug. Methods By using two signal detection methods- PRR and BCPNN, data mining of chidamide tablets was carried out in China adverse drug reaction database between 2014 and 2018. In addition, individual cases of adverse drug reactions documented in China adverse drug reaction database, domestic and foreign literature, and risk management measures in China were analyzed. Results After manual determination and screening, two valuable signals related to chidamide were discovered, namely heart failure and interstitial pneumonia. Conclusion Monitoring of clinical application of chidamide tablets should be enhanced, drug labeling updated without delay and rational application of medicine promoted.

Key words: chidamide, innovative drug, heart failure, interstitial pneumonia, signal detection

CLC Number:

R994.11

WANG Tao, DONG Duo, XIONG Weiyi, TIAN Chunhua, LIU Hongliang. Risk Signals of Innovative Antineoplastic Drug Chidamide Tablets[J]. Chinese Journal of Pharmacovigilance, 2019, 16(10): 614-616.

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