What question did this study set out to answer?

To clarify the safety profile of tigecycline and compare it with manufacturer information.

Adverse Event Profile of Tigecycline: Data Mining of the Public Version of the U.S. Food and Drug Administration Adverse Event Reporting System

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To clarify the safety profile of tigecycline and compare it with manufacturer information.
Analyzed 1,644,220 adverse event reports (AERs) from 2004 to 2009.
Used standardized pharmacovigilance tools for signal detection, including proportional reporting ratio and Bayesian methods.
Removed arbitrary drug names and duplicate submissions for accuracy.
Identified 248 adverse events associated with tigecycline based on 22,017,956 co-occurrences.
Common adverse events included nausea, vomiting, and hepatic failure.
Findings corroborated the manufacturer's information, indicating low risk of unexpected adverse events.

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Data mining assesses tigecycline's safety profile in FDA reports, indicating low risk of unexpected events from off-label uses.

Kadoyama et al. (2012) studied this question.

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