Abemaciclib pharmacovigilance analysis：a real-world analysis of post-marketing surveillance Data

Abstract

Background Abemaciclib is currently the most active Cyclin4/6-dependent kinase inhibitor (CDKI) for the treatment of estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative(HER2−) advanced breast cancer. We explored the potential adverse reactions of Abemaciclib by mining the relevant reported data and tried to provide information for the clinical safe medication. Methods Reporting odds ratio (ROR) was used to detect adverse event signals from the data in the US Food and Drug Administration (FDA) adverse event reporting system database (FAERS). The definition depended on preferred terms (PTs) and system organ class (SOCs) by the Medical Dictionary for Regulatory Activities (MedDRA). Results A total of 5680 reports and 12170 adverse events were retrieved, 55 alert signals were excavated. Among them, the strong signals were "weight decreased”, “blood creatinine increased”, “constipation”, “stomatitis”, “pleural effusion”, “pneumothorax”, ”hot flashes”, ”hypokalemia”, “blood potassium decreased”, “taste disorder”, “eating disorder”, ”renal impairment”, “kidney disease” and “lacrimation increased”. We found that “eating disorder”, “hot flush” and ”pleural effusion” are some new safety signals. The system organ class (SOC) involved in the highest frequency signals mainly focused on abnormal examination parameters and gastrointestinal system diseases. Conclusions Overall, by using the FDA FAERS the present study suggested some new safety signals, which deserve more careful monitoring in clinic.