Comparison of signal detection of tumour necrosis factor- α inhibitors using the Korea Adverse Events Reporting System Database, 2005–2016

ConclusionsSeven new signals that were not included in the current label were identified for TNF α inhibitors and should be updated and monitored.Key Points•Large-scale spontaneous AE reporting data and data mining techniques are useful for detecting signals of rare AEs as well as common AEs induced by drugs.•Drug labels should be updated to reflect signals that are newly discovered by continuous monitoring.

Source: Clinical Rheumatology - October 31, 2019 Category: Rheumatology Source Type: research