Posterior Reversible Encephalopathy Syndrome (PRES) Associated With Lenvatinib: A Disproportionality Analysis
Eleonora Castellana1, Maria Rachele Chiappetta1
1Hospital Pharmacy, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Italy.
Summary
This study found a significant safety signal linking lenvatinib to posterior reversible encephalopathy syndrome (PRES). Increased reporting of PRES suggests a potential association requiring clinical awareness and further investigation.
Area of Science:
- Pharmacovigilance
- Neuro-oncology
- Drug Safety
Background:
- Posterior reversible encephalopathy syndrome (PRES) is a rare neurological condition.
- Lenvatinib is an anticancer therapy with limited reported associations with PRES.
Purpose of the Study:
- Investigate a potential safety signal between lenvatinib and PRES.
- Evaluate disproportionate reporting of PRES with lenvatinib in a spontaneous reporting database.
Main Methods:
- Retrospective pharmacovigilance study using FDA Adverse Event Reporting System (FAERS).
- Disproportionality analysis (ROR, PRR, chi-square) applied to identify safety signals.
- Utilized Evans' criteria for signal detection.
Main Results:
- A statistically significant disproportionality signal for PRES associated with lenvatinib was identified.
- The PRR (5.79) and ROR (5.81) exceeded signal detection thresholds.
- Reports of PRES were more frequent with lenvatinib compared to other drugs.
Conclusions:
- A significant signal suggests a potential association between lenvatinib and PRES.
- Spontaneous reporting systems indicate a signal but cannot confirm causality.
- Clinical awareness and further research are crucial for understanding this adverse event.
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