Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic
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RESEARCH ARTICLE
Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic Simona Dvorackova1 · Katerina Mala‑Ladova1 · Eva Zimcikova1 · Eva Jirsova2 · Stephane Steurbaut3 · Ales Antonin Kubena1 · Jozef Kolar1 · Josef Maly1 Received: 26 July 2020 / Accepted: 11 November 2020 © Springer Nature Switzerland AG 2020
Abstract Background Oral anticoagulants are established drugs of choice for the prevention and treatment of thromboembolic events. However, monitoring their safety remains warranted. Objective The aim was to analyze spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic. Setting Retrospective observational pharmacovigilance study. Methods Adverse drug reaction reports were obtained from the State Institute for Drug Control between January 2005 and November 2017. Reports related to warfarin, dabigatran, apixaban, and rivaroxaban received from healthcare professionals and patients were analyzed. Main outcome measure Frequency and nature of adverse drug reactions reported to oral anticoagulants. Results In total, 297 reports containing 672 adverse drug reactions were received; 269 reports were sent by healthcare professionals (85% by physicians). In 65% of all reports, reactions were due to direct oral anticoagulants. A higher total number of adverse drug reactions was associated with direct oral anticoagulants than with warfarin [reporting odds ratio (ROR): 10.76; confidence interval (CI): 8.70–13.32; p
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