The Problems of Assessment Using Signal Detection of Gastrointestinal Tract Injury Known as Adverse Event Associated with the Oral Non-Steroidal Anti-Inflammatory Drugs

Abstract

Objective: Gastrointestinal tract injury associated with non-steroidal anti-inflammatory drugs (NSAIDs) remains a clinically significant problem.  Therefore, evaluate using the signal detection that is also used clinically and report attention concerning the assessment of known adverse drug events.
Methods: In this study, we analyzed data on the serious adverse event gastrointestinal tract injury collected from 2004 to 2013 using Japanese Adverse Drug Event Report (JADER).  The indicated drugs were classified into 12 NSAIDs based on COX selectivity.
Results: In the usual analysis, several COX-1 selective NSAIDs were detected, but the signals of aspirin and the COX-2-selective NSAIDs etodolac and meloxicam associated with gastrointestinal tract injury were detected using ad hoc analysis.
Conclusion: Since the signal value is calculated from the data obtained from the spontaneous reporting system, it is influenced by the clinical use situation at the time of investigation.  Therefore, the signal value decreases if the risk, for which a countermeasure has been established, is high.  This result does not indicate that COX-1 selective NSAIDs are pharmacologically less risk of gastrointestinal tract injury than COX-2 selective NSAIDs.  There is a need to focus risk on emphasis on NSAIDs signal detected by ad hoc analysis.