Detection of vaccine adverse events before package insert revisions using a Japanese spontaneous reporting system.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of clinical pharmacology"
DOI: 10.1002/jcph.2243
Abstract: The usefulness of disproportionality analysis for the pharmacovigilance of vaccines in Japanese Adverse Drug Event Report (JADER) database is yet to be proven. This study aimed to verify whether significant disproportionality could be detected before… read more here.
Keywords: jader; vaccine adverse; package; insert revisions ... See more keywords
Response to: Eculizumab package insert recommendations for meningococcal vaccinations: call for clarity and a targeted approach for use of the drug in neuromyelitis optica spectrum disorder
Sign Up to like & getrecommendations! Published in 2020 at "CNS Spectrums"
DOI: 10.1017/s1092852920001625
Abstract: Dear Editor, We thank Avasarala et al. for their editorial on meningococcal infection prevention in patients with neuromyelitis optica spectrum disorder (NMOSD) receiving eculizumab. While we appreciate the authors’ concerns and agree that its manufacturers… read more here.
Keywords: vaccination recommendations; vaccine; package insert; neuromyelitis optica ... See more keywords
Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I
Sign Up to like & getrecommendations! Published in 2025 at "Journal of Clinical Psychopharmacology"
DOI: 10.1097/jcp.0000000000001987
Abstract: Abstract Purpose/Background Clozapine was approved in the United States (US) using 1989 regulations and knowledge. After 30 years, many sections of the US package insert (PI) are outdated. Methods We comprehensively reviewed the literature to… read more here.
Keywords: package insert; clozapine metabolism; pharmacology; part ... See more keywords