Adverse reactions of benzodiazepines based on FAERS database

doi:10.19803/j.1672-8629.20210738

Abstract

Abstract: Objective To analyze benzodiazepines-related signals based on the data (1Mar2004-30Sep2020) from the Food and Drug Administration Adverse Event Reporting System (FAERS), and to screen lorazepam a second time in order to contribute to rational use of the drug. Methods Using the frequency method, benzodiazepines-related signals were mined via the Chi-Squared test with Yates’ correction ( χ²_Yates), proportional reporting ratio (PRR) and the lower limit of the 95% confidence interval of the reporting odds ratio (ROR₀₂₅). Results The number of signals related to alprazolam, clobazam, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, oxazepam, quazepam, temazepam and triazolam was 1 345, 582, 1 532, 430, 1 430, 216, 312, 1 699, 618, 98, 1 027 and 330, respectively. Fifty-eight signals were obtained by the second analysis of lorazepam. Conclusion Most of the top 10 benzodiazepine-related signals have been described in drug labels, but most of the lorazepam-related signals mined in the second analysis have not been described in drug labels, so more attention should be paid to such signals in the subsequent use of lorazepam to reduce the side effects of the drug.

Key words: benzodiazepines, lorazepam, FAERS, drug safety

CLC Number:

R971
R994.11

HUANG Liting, TANG Zaixiang, BAI Lu, SHI Guanhong, JIANG Yiguo. Adverse reactions of benzodiazepines based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2022, 19(11): 1223-1227.

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