Adverse events associated with inclisiran: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS).

Abstract

Objective: To gain an improved comprehension of inclisiran safety in real-world settings by data mining from FAERS.

Methods: Data were gathered between 1 December 2020 and 31 December 2023. The Medical Dictionary for Regulatory Activities (MedDRA) corresponding preferred term (PT) and system organ class (SOC) were used to categorize adverse medication reactions in AE reports (AERs). By using reported odds ratio (ROR) method, positive signals were identified.

Results: There were 2,652 reports of inclisiran, and 150 of those AEs had significant disproportionality. Among the 44 PTs with moderate clinical priority, 35 PTs were discovered on the medicine label, including 12 IMEs and 2 DMEs. Of note, 9 PTs were unanticipated AEs that were not discovered in the medication label or reported clinical studies, such as movement disorder (ROR: 3.05; 95%CI: 1.73,5.37), aphonia (ROR: 3.77; 95%CI: 1.79,7.91), and pulmonary congestion (ROR: 3.47; 95%CI: 1.44,8.34). Inclisiran was found to be related to 12 serious AEs. The median TTO of 1896 cases was 13.5 (IQR 0-100) days.

Conclusion: We identified not only known AEs, but also new AE signals such as movement disorder. However, signals does not reveal actual risk, prospective clinical trials are still required to verify their causal connection.