Signal mining and analysis for adverse events of avatrombopag based on FAERS

Abstract

Objective To mine the adverse drug events (ADE) signal of avatrombopag, an effective drug for thrombocytopenia treatment, based on real world data in order to provide reference for its clinical safety application. Methods The OpenVigil2.1 pharmacovigilance platform was used to obtain the ADE report data of avatrombopag from May 2018 to March 2023 in the database of FDA adverse event reporting system (FAERS).The ADE signals were classified and described by the system organ class (SOC) and preferred term (PT) of the ADE terminology set in the Medical Dictionary for Regulatory Activities (MedDRA), and reporting odds ratio (ROR) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard were used to detect the positive ADE signals. Results A total of 1 879 ADE reports related to avatrombopag were obtained, 24 SOCs were involved, and 28 positive ADE signals were detected at PT level.Among these signals, the strongest ones were renal vein thrombosis, portal vein thrombosis and graft versus host disease, while the reports accounting for the largest numbers were headache, fatigue and asthenia.There were 8 ADE signals discovered newly, that is, seasonal allergy, back disorder, musculoskeletal discomfort, flatulence, hypersomnia, rash macular, emotional disorder, and rhinorrhoea. Conclusion For clinical use of avatrombopag, clinicians should not only concern the risk of thrombosis, but also pay close attention to ADE signals such as seasonal allergy, back disorder, musculoskeletal discomfort, flatulence, hypersomnia, rash macular, emotional disorder, and rhinorrhoea that are not documented in the instructions.

Keywords

• avatrombopag
• thrombocytopenia
• adverse events
• fda adverse event reporting system
• data mining