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. 2023 Feb;270(2):975-985.
doi: 10.1007/s00415-022-11450-y. Epub 2022 Nov 3.

Drugs associated with posterior reversible encephalopathy syndrome, a worldwide signal detection study

Alexander Balcerac  1   2 , Kevin Bihan  3 , Dimitri Psimaras  4 , Bénédicte Lebrun-Vignes  3 , Joe-Elie Salem  3 , Nicolas Weiss  5   6
Affiliations

Drugs associated with posterior reversible encephalopathy syndrome, a worldwide signal detection study

Alexander Balcerac et al. J Neurol. 2023 Feb.

Abstract

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: 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 IC0.25 (lower end of the IC 95% credibility interval) > 0 is considered statistically significant.

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 IC0.25 > 0. Only 34% (N = 25/73) of them had this information written in the summary of product characteristics. The main drug classes involved were antineoplastic and immunomodulating agents and the drugs with the greatest number of cases were tacrolimus, cyclosporin, bevacizumab, methotrexate, and vincristine. An overall mortality of 8.1% (N = 267/3278) was identified in cases of drug-associated PRES.

Conclusion: 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.

Keywords: Drug; PRES; Pharmacovigilance; Posterior reversible encephalopathy syndrome; Reversible posterior leukoencephalopathy syndrome; VigiBase.

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References

    1. Sudulagunta SR, Sodalagunta MB, Kumbhat M, Settikere Nataraju A (2017) Posterior reversible encephalopathy syndrome(PRES). Oxf Med Case Rep 2017(4):omx011 - DOI
    1. Lee VH, Wijdicks EFM, Manno EM, Rabinstein AA (2008) Clinical spectrum of reversible posterior leukoencephalopathy syndrome. Arch Neurol 65(2):205–210 - DOI
    1. Legriel S, Schraub O, Azoulay E, Hantson P, Magalhaes E, Coquet I et al (2012) Determinants of recovery from severe posterior reversible encephalopathy syndrome. PLoS ONE 7(9):e44534 - DOI
    1. Alhilali LM, Reynolds AR, Fakhran S (2014) A multi-disciplinary model of risk factors for fatal outcome in posterior reversible encephalopathy syndrome. J Neurol Sci 347(1–2):59–65 - DOI
    1. Legriel S, Lerner A, Wintermark M, Rykken JB, Gao B (2020) Editorial: posterior reversible encephalopathy syndrome and associated diseases. Front Neurol [Internet]. [cité 16 janv 2022];11. Disponible sur: https://www.frontiersin.org/article/10.3389/fneur.2020.00667

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