Adverse drug reactions profiles for abiraterone and enzalutamide: A pharmacovigilance descriptive analysis

Objective. The aim of this study was to describe the profile of adverse drug reactions (ADRs) observed with abiraterone and enzatutamide, based on cases registered in the French regional pharmacovigitance centres to identify potential pharmacovigitance signals. Methods. We extracted from the French pharmacovigitance database all cases of ADRs or drug interactions involving abiraterone or enzatutamide from the time they market authorization date until December 31st, 2017. Signal detection results have been transmitted by the French Agency for Health Products (ANSM). The data were compared with those of the risk management plans for each drug and the literature. Results. Among the 233 observations analyzed, nearly 62% involved abiraterone as a suspect drug and 38% involved enzatutamide; only 1 case involved both drugs. The ADRs profile is different between the drugs. Abiraterone is mostly associated with expected cardiac diseases (heart failure, and QT prolongation), expected with the drug. Also described, several cases of hepatotoxicity have been reported, however some cases with fatal outcome suggest that despite a follow-up of the liver function tests, it is difficult to anticipate this risk. Signals concerning acute renal failure and ischemic stroke have arisen. Enzatutamide is more particularly associated with various neurological disorders (convulsions, hallucinations, fatigue, and memory impairment) expected with the drug. White ischemic heart disease is also expected, signals of heart failure and atrial fibrillation have arisen. A potential hepatotoxicity of the molecule is discussed because of cases of cholestatic hepatitis. Conclusion. The analysis of the French pharmacovigitance database cases allows to confirm an expected and monitored risk profile in the risk management plan for both drugs. Several signals have arisen, some of which will be investigated through a pharmacoepidemiology study. (C) 2020 Societe francaise de pharmacologie et de therapeutique. Published by Elsevier Masson SAS. All rights reserved.