Drugs associated with posterior reversible encephalopathy syndrome, a worldwide signal detection study.
Drug
PRES
Pharmacovigilance
Posterior reversible encephalopathy syndrome
Reversible posterior leukoencephalopathy syndrome
VigiBase
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Feb 2023
Feb 2023
Historique:
received:
22
08
2022
accepted:
22
10
2022
revised:
21
10
2022
pubmed:
5
11
2022
medline:
2
2
2023
entrez:
4
11
2022
Statut:
ppublish
Résumé
Posterior reversible encephalopathy syndrome (PRES) can occur in a variety of clinical conditions, such as severe hypertension, pregnancy, inflammatory diseases, hematopoietic stem cells or solid organ transplantation. Apart increased blood pressure levels and altered renal function, several drugs have been reported as potential triggering factor. These descriptions are nevertheless limited to case reports or small case series. Systematic analysis of drugs associated with PRES using global pharmacovigilance database is lacking and can be useful. We performed a disproportionality analysis using VigiBase, the World Health Organization pharmacovigilance database, using the information component (IC). The IC compares observed and expected values to find associations between drugs and PRES using disproportionate Bayesian reporting. An IC Here we present an analysis of 3278 cases of PRES reported in VigiBase. These results identified 73 molecules statistically associated with PRES using full database as background with an IC These results will help clinicians identify potential suspected drugs associated with PRES and decide which drug to discontinue and eventually lead to a re-evaluation of drug labels for some molecules.
Sections du résumé
BACKGROUND
BACKGROUND
Posterior reversible encephalopathy syndrome (PRES) can occur in a variety of clinical conditions, such as severe hypertension, pregnancy, inflammatory diseases, hematopoietic stem cells or solid organ transplantation. Apart increased blood pressure levels and altered renal function, several drugs have been reported as potential triggering factor. These descriptions are nevertheless limited to case reports or small case series. Systematic analysis of drugs associated with PRES using global pharmacovigilance database is lacking and can be useful.
METHODS
METHODS
We performed a disproportionality analysis using VigiBase, the World Health Organization pharmacovigilance database, using the information component (IC). The IC compares observed and expected values to find associations between drugs and PRES using disproportionate Bayesian reporting. An IC
RESULTS
RESULTS
Here we present an analysis of 3278 cases of PRES reported in VigiBase. These results identified 73 molecules statistically associated with PRES using full database as background with an IC
CONCLUSION
CONCLUSIONS
These results will help clinicians identify potential suspected drugs associated with PRES and decide which drug to discontinue and eventually lead to a re-evaluation of drug labels for some molecules.
Identifiants
pubmed: 36329183
doi: 10.1007/s00415-022-11450-y
pii: 10.1007/s00415-022-11450-y
doi:
Substances chimiques
Methotrexate
YL5FZ2Y5U1
Tacrolimus
WM0HAQ4WNM
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
975-985Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
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