Comparison of adverse drug reactions of heparin and its derivates in the European Economic Area based on data from EudraVigilance between 2017 and 2021

Hemodialysis patients need long-term frequent use of parenteral anticoagulants, and the side effects need to be taken seriously. This study aimed to assess the reporting of adverse drug reactions (ADRs) following administration of unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, and danaparoid, in relation to their usage in European Economic Area (EEA). The total number of ADRs of each anticoagulant between 2017 to 2021 was collected using data from the EudraVigilance database. The number of hemorrhages, thrombocytopenia, injection-site reaction, liver injury, hypersensitivity and bone disorder were collected, respectively. Usage of these anticoagulants was estimated using sales data from the IQVIA MIDAS database. The reporting rates of ADRs were calculated and compared using χ Between 2017 and 2021 in the EEA, the overall ADRs reporting rates per 10,000,000 standard units (SU) of UFH, enoxaparin, nadroparin, dalteparin, fondaparinux, and danaparoid were 12.3, 40.8, 23.6, 36.5, 91.4, and 430.0, respectively. There were significant differences among these drugs (χ The reporting rates of ADRs for heparin and its derivates were all very low. In comparison, the reporting rate of ADRs for danaparoid and fondaparinux was relatively high. The most commonly reported ADRs were hemorrhage, thrombocytopenia, followed by injection-site reactions and hypersensitivity.