Adverse drug reactions profiles for abiraterone and enzalutamide: A pharmacovigilance descriptive analysis
Lucie-Marie Scailteux 1, Clémence Lacroix 2, Sandrine Bergeron 3, Fabien Despas 4, Marion Sassier 5, Louise Triquet 6, Sylvie Picard 6, Emmanuel Oger 7, Elisabeth Polard 7; et le réseau français des Centres régionaux de pharmacovigilance
Abstract
Objective:
This study aimed to characterize the adverse drug reaction (ADR) profiles of abiraterone and enzalutamide using cases reported to French regional pharmacovigilance centres, with the goal of identifying potential pharmacovigilance signals.
Methods:
All cases of ADRs or drug interactions involving abiraterone or enzalutamide were retrieved from the French pharmacovigilance database, covering the period from each drug’s marketing authorization to December 31, 2017. Signal detection results provided by the French Agency for Health Products (ANSM) were compared with information from each drug’s risk management plan and relevant literature.
Results:
Of the 233 cases analyzed, 62% involved abiraterone, 38% involved enzalutamide, and 1 case involved both drugs. The ADR profiles differed between the two agents.
Abiraterone was predominantly linked to expected cardiac disorders, including heart failure and QT prolongation. Several cases of hepatotoxicity were also reported; some were fatal, indicating that routine liver function monitoring may not always prevent severe outcomes. Signals for acute renal failure and ischemic stroke were also observed.
Enzalutamide was mainly associated with neurological disorders—such as seizures, hallucinations, fatigue, and memory impairment—consistent with its known safety profile. While ischemic heart disease was expected, new signals emerged for heart failure and atrial fibrillation. Potential hepatotoxicity was also discussed due to reported cases of cholestatic hepatitis.
Conclusion:
The French pharmacovigilance database confirms the expected and monitored ADR profiles outlined in the risk management plans for both drugs. However, several new safety signals have been identified, warranting Enzalutamide further investigation through pharmacoepidemiological studies.