Mining and analysis of ixazomib citrate capsules safety signals based on FAERS database

doi:10.19803/j.1672-8629.20230408

Abstract

Abstract: Objective To mine and analyse the potential adverse event (AE) risk signals of ixazomib citrate capsules post-marketing to provide a reference for its rational clinical application. Methods Extract the FAERS database of AE reported for Ixazomib citrate capsules from marketing (November 2015) to March 31,2023, data cleaning and de-duplication and standardization. Signal mining was performed using the Reported Ratio (ROR) and Bayesian Confidence Progressive Neural Network (BCPNN) methods. Results A total of 14 156 AE were reported in the database with Ixazomib citrate capsules as the primary suspect. Mining by ROR and BCPNN methods resulted in 204 potential positive PTs, involving 17 SOC. Among them, there are 156 PT signals that are not specified in drug instruction, including the new and relatively serious AE such as death, cardiovascular system and renal-urinary system, which require high clinical attention. Conclusion Mining the real-world adverse events of ixazomib citrate capsules suggests that the clinical caution in evaluating its AE risk factors and strengthening the medication monitoring to ensure the safety of the medication for the patients.

Key words: ixazomib citrate capsules, proteasome inhibitors, signal mining, FDA adverse event reporting system (FAERS), adverse drug event

CLC Number:

HAO Xiaohui, ZHANG Ping, WU Lulu, WANG Lihua. Mining and analysis of ixazomib citrate capsules safety signals based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1427-1431.

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