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Adverse drug reactions with oral anticoagulants: data from sicilian spontaneous reporting system database
- Source :
- Journal of Clinical Pharmacy and Therapeutics. 46:1027-1040
- Publication Year :
- 2021
- Publisher :
- Hindawi Limited, 2021.
-
Abstract
- Objective Direct oral anticoagulants (DOACs) were developed to avoid the limitations of vitamin K antagonists (VKAs). DOACs are associated with a greater incidence of gastrointestinal bleeding and a smaller number of intracranial haemorrhages than VKAs. Therefore, it is important to deepen our knowledge of their safety profiles. The aim of this study was thus to analyse adverse drug reaction (ADR) reports on DOACs and VKAs using the Sicilian Spontaneous Reporting System (SRS) database. Methods All ADR reports with DOACs and VKAs as suspected drugs that were entered into the Sicilian SRS database during the period 2001-2019 were selected. In detail, all reports with the following single active substances were included: dabigatran etexilate, rivaroxaban, apixaban and edoxaban; acenocoumarol and warfarin were included as a comparator group. Descriptive statistical methodology was used to evaluate characteristics of the reported cases with a case-by-case assessment. Results and discussion Out of 521 reports related to anticoagulants, 444 (85.2%) and 77 (14.8%) involved DOACs and VKAs, respectively. DOAC-related reports were mainly of gastrointestinal disorders. In contrast, VKAs were mostly associated with blood and lymphatic system disorders, injury, investigations and vascular disorders. Many more cases of ADRs in the form of gastrointestinal disorders concerned dabigatran etexilate (n = 179, 73.7%) than the other DOACs, while ADRs in the form of blood disorders were mainly associated with acenocoumarol (n = 27, 57.4%). The most commonly reported Preferred Terms for DOACs were dyspepsia (n = 89, 17.1%), upper abdominal pain (n = 41, 9.2%) and pruritus (n = 26, 5.8%), whereas for VKAs, they were anaemia (n = 21, 27.3%) and hypocoagulable state (n = 18, 3.5%). Potentially interacting concomitant medications particularly included antithrombotic agents (n = 19, 4.3%) for DOACs and proton-pump inhibitors (PPIs) (n = 37, 48.1%) and antithrombotic agents (n = 13, 16.9%) for VKAs. Conclusion The ADRs most commonly associated with DOACs, especially dabigatran, were gastrointestinal disorders, particularly gastrointestinal bleeding. Our study also highlights the potential role of drug-drug interactions in the ADRs. The cases of gastrointestinal bleeding highlight the need for careful prescribing of DOACs and use of potentially interacting concomitant drugs.
- Subjects :
- vitamin K antagonist
Gastrointestinal bleeding
Vitamin K
Gastrointestinal Diseases
adverse drug reaction
spontaneous reporting
direct oral anticoagulant
computer.software_genre
030226 pharmacology & pharmacy
Dabigatran
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Edoxaban
medicine
Adverse Drug Reaction Reporting Systems
Humans
Drug Interactions
Pharmacology (medical)
030212 general & internal medicine
Pharmacology
Rivaroxaban
Acenocoumarol
Database
business.industry
Warfarin
Anticoagulants
medicine.disease
Italy
chemistry
pharmacovigilance
Apixaban
Gastrointestinal Hemorrhage
business
Intracranial Hemorrhages
adverse drug reaction, direct oral anticoagulant, pharmacovigilance, spontaneous reporting, vitamin K antagonist
computer
Adverse drug reaction
Factor Xa Inhibitors
medicine.drug
Subjects
Details
- ISSN :
- 13652710 and 02694727
- Volume :
- 46
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Pharmacy and Therapeutics
- Accession number :
- edsair.doi.dedup.....0036873ed1286f81807680b6f92a15fb