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

Fei-Lin Ge; Ming Niu; Zi-Xin Han; Jun-Ling Cao; Jia-Bo Wang; Zhao-Fang Bai; Hai-Bo Song; Yu-Ming Guo; Xiao-He Xiao

doi:10.1007/s11655-021-3442-2

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

Chin J Integr Med. 2021 Nov;27(11):832-837. doi: 10.1007/s11655-021-3442-2. Epub 2021 May 8.

Authors

Fei-Lin Ge^{1

2}, Ming Niu², Zi-Xin Han², Jun-Ling Cao³, Jia-Bo Wang², Zhao-Fang Bai², Hai-Bo Song⁴, Yu-Ming Guo⁵, Xiao-He Xiao²

Affiliations

¹ School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, 100029, China.
² Department of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
³ Department of Pharmacy, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China.
⁴ Center for Drug Reevaluation, National Medical Products Administration, Beijing, 100022, China. Songhaibo@cdr.gov.cn.
⁵ Department of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. guoyuming_0520@126.com.

PMID: 33963478
DOI: 10.1007/s11655-021-3442-2

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<0.05). It was found that 10.43% of 355 cases may be involved with irrational drug use, including overdose, repeated medication, and combination of multiple drugs. There were 190 cases which used BGZP (non-combination), and they were mainly for common in diseases caused by abnormal immune activation (accounting for 40.53% of the total cases). Especially at the age group with the most cases with age of 41-50 years, the cases associated with immunological diseases of female were obviously more than that of male (P<0.05). The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days, and the median latency was 27.5 days, along with the range of cumulative dose (0.45-520.02 g) as well as the daily dose (0.09-2.64 g/d) after the conversion.

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.

Keywords: Psoraleae Fructus; drug safety; hepatobiliary adverse drug reaction; pharmacovigilance.

MeSH terms

Adult
Adverse Drug Reaction Reporting Systems
Chemical and Drug Induced Liver Injury* / etiology
Drug-Related Side Effects and Adverse Reactions*
Female
Humans
Male
Middle Aged
Pharmacovigilance
Retrospective Studies