A systematic comparison of hepatobiliary adverse drug reactions in FDA and EMA drug labeling reveals discrepancies

Yue Wu,Wenzhong Xiao,Weida Tong,Jürgen Borlak,Minjun Chen

Drug Discovery Today（2022）

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摘要

•Systematic comparison of 549 medications was conducted between FDA and EMA labeling.•Our analysis found limited discrepancies in hepatic safety information.•The discrepancies were mainly associated with non-severe or low-frequency hepatic adverse events.

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关键词

Drug labeling,Adverse drug reactions,Contraindication,Warnings and precautions,Drug-induced liver injury,FDA,EMA,LiverTox

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