Toxicities with Immune Checkpoint Inhibitors: Emerging Priorities From Disproportionality Analysis of the FDA Adverse Event Reporting System
Sign Up to like & getrecommendations! Published in 2019 at "Targeted Oncology"
DOI: 10.1007/s11523-019-00632-w
Abstract: BackgroundImmune checkpoint inhibitors (ICIs), including antibodies targeting cytotoxic T-lymphocyte associated protein 4 (CTLA4) and programmed cell death 1 or its ligand (PD1/PDL1), elicit different immune-related adverse events (irAEs), but their global safety is incompletely characterized.ObjectiveThe… read more here.
Keywords: reporting; checkpoint inhibitors; disproportionality; pd1 pdl1 ... See more keywords
Decrease in therapeutic effect among botulinum neurotoxin type A agents: Analysis of the fda adverse event reporting system database
Sign Up to like & getrecommendations! Published in 2018 at "Toxicon"
DOI: 10.1016/j.toxicon.2018.11.141
Abstract: • There are three FDA (Food and Drug Administration) approved botulinum toxin type A (BoNT-A) agents: onabotulinumtoxinA (Botox; Allergan, Inc.; initial FDA approval 1989), abobotulinumtoxinA (Dysport; Galderma Laboratories, L.P. for cosmetic; initial FDA approval 2009),… read more here.
Keywords: adverse event; effect; fda adverse; type ... See more keywords
1407. Disproportionality Analysis of Safety with Nafcillin and Oxacillin with the FDA Adverse Event Reporting System (FAERS)
Sign Up to like & getrecommendations! Published in 2018 at "Open Forum Infectious Diseases"
DOI: 10.1093/ofid/ofy210.1238
Abstract: Abstract Background Antistaphylococcal penicillins including oxacillin and nafcillin are among the drugs of choice for severe and invasive MSSA infections. While alternative agents such as cefazolin are associated with improved safety compared with antistaphylococcal penicillins,… read more here.
Keywords: reporting; safety; nafcillin oxacillin; fda adverse ... See more keywords
Multiple Sclerosis immunotherapies and COVID-19 mortality: an analysis of the FDA Adverse Event Reporting System
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DOI: 10.1177/17562864221129383
Abstract: Background: Evidence on mortality risks associated with MS-immunotherapies during the SARS-CoV2 pandemic derived thus far mainly from single country experiences. Objective: In this analysis, we aim to determine the frequency of COVID-19 associated fatality reports… read more here.
Keywords: system; fda adverse; event reporting; mortality ... See more keywords
Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system
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DOI: 10.3389/fimmu.2023.1169735
Abstract: Background Risankizumab, a humanized IgG1 monoclonal antibody that selectively inhibits IL-23, is currently approved for the treatment of moderate-to-severe plaque psoriasis and Crohn’s disease. The real-world safety study of risankizumab in a large- sample population… read more here.
Keywords: fda adverse; reporting system; event reporting; adverse event ... See more keywords