Real-world pharmacovigilance analysis of galsulfase: a study based on the FDA adverse event reporting system (FAERS) database
This investigation delivers an exhaustive and indicative assessment of galsulfase's safety profile, grounded in authentic, real-world evidence. The findings emphasis the importance of continuous safety surveillance and the emergence of new AEs. The identification of previously unreported urologic adverse events, such as glomerulonephritis membranous and nephritic syndrome, warrants further investigation. The study emphasizes the need for enhanced pharmacovigilance to ensure patient safety and the effectiveness of galsulfase treatment.
Authors
- Jun Yang (ORCID: https://orcid.org/0000-0002-9401-3528)
- Junjie Zou (ORCID: https://orcid.org/0000-0002-4824-400X)
- Jiao Qian (ORCID: https://orcid.org/0000-0003-3497-2310)
- Yuanyuan Meng (ORCID: https://orcid.org/0000-0002-1338-0132)
- Shangze Li
- Runcheng Huang
- Yijia Liu
Institutions
- Second Military Medical University (CN)
- Shanghai Changzheng Hospital (CN)
- Changhai Hospital (CN)
Publication Details
- Journal
- Frontiers in Pharmacology
- Published
- 2024-08-05
- DOI
- https://doi.org/10.3389/fphar.2024.1420126
- Citations
- 1
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.35
Funders
- Science and Technology Commission of Shanghai Municipality
- Second Military Medical University
- National Key Research and Development Program of China