ABSTRACT
BACKGROUND: Cancer is one of the leading causes of death globally. Owing to high toxicity, patients using chemotherapy drugs have a higher risk for developing adverse drug reactions (ADRs). Pharmacovigilance studies are essential in oncology to evaluate ADRs caused by anticancer drugs and improve patient safety. This study aimed to analyze serious ADRs associated with the use of doxorubicin and epirubicin reported to VigiBase. METHOD: All anonymized data on suspected ADRs for doxorubicin and epirubicin as 'serious' and 'suspected' or 'interacting' drugs between 1968 and 30 August 2021, were extracted from VigiBase. Descriptive statistics were conducted in Microsoft Excel, and data were summarized using frequencies and percentages. RESULTS: A total of 35,620 serious individual case safety reports was analyzed. The majority of reports were from females (Dox = 61.41%; Epi = 86.56%), while the predominant age group was 45-64 years (Dox = 42.06%; Epi = 57.39%). Physicians were the more likely group to report serious ADRs (Dox = 50.03%; Epi = 34.11%). In general, Europe reported the highest for doxorubicin (38.08%), while Asia recorded the highest reports for epirubicin (53.28%). Oceania reported the least for both drugs (Dox = 0.45%; Epi = 0.04%), followed by Africa (Dox = 0.72%; Epi = 0.29%). Blood and lymphatic system disorders were the most reported serious category (Dox = 11053 [44.47%]; Epi = 6659 [61.84%]). The most common manifestations were febrile neutropenia (Dox = 10.52%) and bone marrow failure (Epi = 23.89%). CONCLUSION: This study provides relevant global insights into serious ADRs for doxorubicin and epirubicin. This knowledge may assist in minimizing and proactively managing ADRs. It can also inform policies to improve patients' quality of life.
