Prioritization of adverse events related to integrase inhibitors and NNRTIs: a disproportionality analysis using data from the FAERS database - PubMed
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- #Adverse Events
- #HIV
- #Pharmacovigilance
- Study prioritizes adverse events (AEs) related to integrase inhibitors (INSTIs) and NNRTIs using FAERS database.
- Multi-criteria score evaluated clinical relevance, reporting proportion, case fatality rate, and signal stability.
- Identified 4487 low-priority (0-2 points), 1849 moderate-priority (3-5 points), and 26 high-priority (>5 points) AEs.
- Five noteworthy AEs remained after case-by-case assessment: efavirenz-related haemolytic anaemia, etravirine-related hepatic failure, dolutegravir-related foetal death, raltegravir-related DRESS, and raltegravir-related hepatic failure.
- Provides a systematic framework for evaluating post-marketing AEs of INSTIs and NNRTIs, highlighting high-priority AEs needing further investigation.