Published 2025-01-01
“…Despite anecdotal reports linking multiple drugs to PV, corroborating evidence from large datasets is
missing.ObjectiveTo examine the extent to which previously reported associations between a comprehensive list of 36 drugs implicated in PV pathogenesis could be replicated using population-level pharmacovigilance data.DesignSeries of observational, retrospective, case-control, pharmacovigilance analyses (one analysis/drug, 36 total).SettingPopulation based.ParticipantsIndividuals who submitted a report of a drug-related adverse event to the FDA from Q4 of
2003 to Q2 of 2023.ExposureCases were identified by the presence of adverse events described by the MedDRA preferred term “pemphigus” (10034280) and then sorted based on exposure to each of the drugs of interest.Main outcomes and measuresReporting Odds Ratios (RORs) quantifying the association between a given drug exposure and reports of pemphigus adverse events.ResultsThe analyses revealed statistically significant associations between reports of pemphigus and exposure to 11/36 previously reported drugs, two of which had particularly high RORs (>200) [gold sodium thiomalate (ROR, 266.0; 95% CI, 202.6-349.3) and hydroxychloroquine (ROR, 282.6; 95% CI, 261.0-306.1)], three had very strong RORs (14-45) [penicillamine (ROR, 30.5; 95% CI, 11.4-81.7), piroxicam (ROR, 14.8; 95% CI, 8.2-26.7), and imiquimod (ROR, 42.3; 95% CI, 26.2-68.3)], and six had modestly strong RORs (2-5) [rifampin (ROR, 2.8; 95% CI, 1.4-5.6), hydrochlorothiazide (ROR, 1.6; 95% CI, 1.2-2.1), irbesartan (ROR, 2.7; 95% CI, 1.6-4.4), lisinopril (ROR, 5.3; 95% CI, 4.5-6.2), nivolumab (ROR, 2.7; 95% CI, 1.8-4.1), and nifedipine (ROR, 3.0; 95% CI, 1.9-5.0)]. …”
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