Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system / 中国药房

OBJECTIVE To provide reference for the clinically safe application of acalabrutinib by mining and analyzing the risk signals of adverse drug events （ADE）. METHODS The acalabrutinib-induced ADE reports were extracted from the U.S. FDA adverse event reporting system using the OpenVigil 2.1 platform from November 1， 2017 to March 31， 2023. The reporting odds ratio （ROR） method and composite criteria method from the Medicines and Healthcare Products Regulatory Agency （MHRA） were used for detection of ADE signals. RESULTS There were 7 869 ADE reports of acalabrutinib as the primary suspect drug and 142 ADE positive signals were detected from them， involving 20 system organ classes， which was generally consistent with the ADE recorded in the drug instruction of acalabrutinib， mainly involving general disorders and administration site conditions， various inspection， blood and lymphatic system disorders， various neurological disorders and cardiac disorders. In addition， this study identified several new potential ADE signals that were not mentioned in the drug instruction， including sudden cardiac death， pulmonary toxicity， tumor lysis syndrome， pleural effusion， dyspepsia， gastroesophageal reflux disease， bone pain， decreased blood pressure， and abnormal blood sodium， etc. CONCLUSIONS When using acalabrutinib， in addition to paying attention to the ADE recorded in its instructions， the risk of serious ADE that may lead to death， such as sudden cardiac death and pulmonary toxicity， should also be evaluated to avoid or reduce the occurrence of ADE as much as possible.

Data Mining for Adverse Events Signals of Acalabrutinib Based on FAERS Database / 肿瘤防治研究

Objective To explore the potential adverse reactions of acalabrutinib by mining and analyzing the pharmacovigilance signal of acalabrutinib, to provide a reference for clinically safe and rational drug use. Methods Data related to acalabrutinib in the FAERS database were searched, and pharmacovigilance signals were obtained using the disproportionality measurement. Results A total of 3, 155 reports of adverse events with acalabrutinib as the primary suspected drug were extracted, and 73 warning signals were detected involving 15 system organ classifications, 36 of which were not included in the drug instructions of acalabrutinib. The strong signals of acalabrutinib were mainly concentrated in various inflammatory and bleeding, anemia, contusion, atrial fibrillation, and so on. The largest number of system organ classification signals were focused on the blood and lymphatic system disorders, investigations, infections, and so on. In addition, the drug may cause tachycardia, brittle nails, and other warning signs. Through further analysis of gender-related adverse events, there were a total of 49 high-risk signals with gender differences found. Herein, male patients should pay attention to adverse reactions in bleeding, heart, urinary system, hypertension, and so on; meanwhile, female patients should be alert to adverse reactions in liver function, skin inflammation, and so on. Conclusion A total of 36 drug warning signs that are not mentioned in the instructions for acalabrutinib are mined using FAERS, and blood, infection, and cardiac toxicity require special attention. Thus, these signals should be detected promptly for effective prevention in clinical medication to reduce the risk of medication use for patients.