Pharmacovigilance analysis of orlistat adverse events based on the FDA adverse event reporting system (FAERS) database
Jinfeng Zhu,
Mianda Hu,
Yingshi Liang,
Mingjun Zhong,
Zilin Chen,
Zhenjie Wang,
Yujia Yang,
Ziyi Luo,
Wenqi Zeng,
Jiahui Li,
Yikuan Du,
Yi Liu,
Chun Yang
Affiliations
Jinfeng Zhu
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Mianda Hu
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Yingshi Liang
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Mingjun Zhong
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Zilin Chen
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Zhenjie Wang
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Yujia Yang
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Ziyi Luo
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Wenqi Zeng
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Jiahui Li
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China
Yikuan Du
Central Laboratory, The Tenth Affiliated Hospital of Southern Medical University, Dongguan, 523059, China; Corresponding author. Central Laboratory, The Tenth Affiliated Hospital of Southern Medical University, Dongguan,523059, China.
Yi Liu
The First Dongguan Affiliated Hospital, Guangdong Medical University, Dongguan, 523808, China
Chun Yang
Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, The First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, Dongguan, 523808, China; Corresponding author. Dongguan Key Laboratory of Stem Cell and Regenerative Tissue Engineering, the First Dongguan Affiliated Hospital, School of Basic Medical Sciences, Guangdong Medical University, No. 1, Xincheng Road, Songshanhu, Dongguan Guangdong Province, 523808, China.
Objective: Based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, we analyzed the signals of potential adverse events (AEs) of orlistat in the real world to provide a reference for its safe clinical use. Methods: The FAERS database and OpenVigil 2.1 were used to obtain data on adverse events of orlistat from the first quarter of 2004 to the first quarter of 2023, and to analyze the population in which the adverse events occurred. And the signals of their potential adverse events were mined using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and empirical Bayesian geometric mean (EBGM). Result: A total of 21,079 reports of adverse events with orlistat as the primary suspected drug were collected in this study. Using four disproportionate analyses, we screened 117 preferred terms (PTs) involving 18 system organ classes (SOCs). We found that the most common adverse events at SOC level for orlistat remained ''gastrointestinal disorders'', while ''metabolism and nutrition disorders'', ''renal and urinary disorders'', ''musculoskeletal and connective tissue disorders'' and ''hepatobiliary disorders'' also ranked high in the number of case reports. In addition, at the PT level, we identified several new signals of adverse events not mentioned in the specification, including ''lipiduria'', ''anal haemorrhage'', ''rectal haemorrhage'', ''haematochezia'', ''sigmoiditis'', ''diverticulitis'' and ''muscle spasms''. Conclusion: Most of the adverse events found in this study are consistent with the results described in the drug label. At the same time, we also found some new adverse events, which require more prospective studies to verify and elucidate their relationship with orlistat.
