Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance.

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From: Chinese Journal of Integrative Medicine(Vol. 27, Issue 11)
Publisher: Springer
Document Type: Report
Length: 400 words

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Keywords: drug safety; hepatobiliary adverse drug reaction; Psoraleae Fructus; pharmacovigilance Abstract Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus (BGZP) related with hepatobiliary adverse drug reactions (ADR), in order to reinforce pharmacovigilance. Methods A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016. Serious and general ADRs were analyzed and assessed. Results There were 355 cases of hepatobiliary ADR related to BGZP. Both the amount of cases and the proportion of serious ADR showed an increasing growth by years (P Conclusions Cases of hepatobiliary ADR related to BGZP showed significant individual differences, and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR. It may be similar with idiosyncratic drug-induced liver injury, and recommended that BGZP should be used with more caution under monitoring liver function, especially in female patients with immunological diseases. Author Affiliation: (1) School of Chinese Materia Medica, Beijing University of Chinese Medicine, 100029, Beijing, China (2) Department of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, 100039, Beijing, China (3) Department of Pharmacy, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, 100078, Beijing, China (4) Center for Drug Reevaluation, National Medical Products Administration, 100022, Beijing, China (g) Songhaibo@cdr.gov.cn (h) guoyuming_0520@126.com Article History: Registration Date: 05/07/2021 Accepted Date: 01/13/2021 Online Date: 05/08/2021 Byline: Fei-lin Ge (1, 2), Ming Niu (2), Zi-xin Han (2), Jun-ling Cao (3), Jia-bo Wang (2), Zhao-fang Bai (2), Hai-bo Song (corresponding author) (4, g), Yu-ming Guo (corresponding author) (2, h), Xiao-he Xiao (2)

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Gale Document Number: GALE|A681341754