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Drug-Related Glomerular Phenotypes: A Global Pharmacovigilance Perspective
Alexandre Baptista1,2, Ana M Macedo1,2, Ana Marreiros1,2
1School of Medicine and Biomedical Sciences, Algarve University (UAlg), 8005-139 Faro, Portugal.
Adverse drug reactions, particularly glomerular disorders, are linked to medications lacking known nephrotoxic roles. VigiBase data reveals new potential drug-induced kidney injury concerns, requiring further study.
Area of Science:
- Pharmacovigilance
- Nephrology
- Drug Safety
Background:
- Adverse drug reactions (ADRs) are a growing concern due to increased medication use.
- Glomerular disorders are frequently reported renal conditions linked to drug use.
- VigiBase is a key global pharmacovigilance database for ADRs.
Purpose of the Study:
- To identify primary medications associated with glomerular disorders using VigiBase data.
- To assess the nephrotoxic potential and disproportionality of drugs linked to glomerular disorders.
Main Methods:
- Analysis of 54 years of VigiBase spontaneous ADR notifications.
- Evaluation based on global frequencies, disproportionality (IC025), nephrotoxic potential, and physiopathological mechanisms.
- Extraction of 106,775 notifications related to drug-associated glomerular disorders.
Main Results:
- 47% of implicated medications were classified as potential nephrotoxins; 40% lacked prior scientific references.
- Inotersen, Penicillamine, Bevacizumab, and Lenvatinib showed the strongest association (IC025 values 5.4-8.3).
- Non-nephrotoxic drugs exhibited high disproportionality, suggesting novel nephrotoxic potential.
Conclusions:
- Drug-induced glomerular disorders are significantly associated with drugs not previously recognized for nephrotoxicity.
- High disproportionality indices in VigiBase indicate potential new nephrotoxins.
- Further dedicated studies are needed to confirm the nephrotoxic potential of these newly implicated drugs.
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