Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic

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 Rep...

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Bibliographic Details
Published in:International journal of clinical pharmacy 2021-08, Vol.43 (4), p.948-957
Main Authors: Dvorackova, Simona, Mala-Ladova, Katerina, Zimcikova, Eva, Jirsova, Eva, Steurbaut, Stephane, Kubena, Ales Antonin, Kolar, Jozef, Maly, Josef
Format: Article
Language:English
Subjects:
Anticoagulants
Hemorrhage
Internal Medicine
Medicine
Medicine & Public Health
Pharmacovigilance
Pharmacy
Research Article
Thromboembolism
Warfarin
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Summary: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 
ISSN:2210-7703
2210-7711
DOI:10.1007/s11096-020-01201-2