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The FAERS database is subject to reporting bias, lacks denominator data (total number of patients exposed), and cannot distinguish between coincidental associations and true drug-related effects

An et al., 2019

doi: 10.1152/ajpgi.00076.2012 [DOI] [PubMed] [Google Scholar] 22

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Moreover, inflammatory mediators can stimulate the distal terminals of DRG neurons, which in turn transmit sensory information to the central nervous system

However, clinical outcomes have been variable, highlighting the need for optimized trial designs, improved biomarkers, and patient stratification