scholarly journals Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions

2017 ◽  
Vol 83 (7) ◽  
pp. 1532-1543 ◽  
Author(s):  
Luca Monaco ◽  
Chiara Biagi ◽  
Valentino Conti ◽  
Mauro Melis ◽  
Monia Donati ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Safety Profile ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Drug Reactions

scholarly journals Adverse Drug Reactions during Real-Life Use of Direct Oral Anticoagulants in Italy: An Update Based on Data from the Italian National Pharmacovigilance Network

2020 ◽  
Vol 10 (4) ◽  
pp. 266-276 ◽  
Author(s):  
Carlo Lavalle ◽  
Luca Di Lullo ◽  
Antonio Bellasi ◽  
Claudio Ronco ◽  
Stefano Radicchia ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Market Share ◽  
Adverse Drug Reactions ◽  
Oral Anticoagulants ◽  
Risk Index ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Drug Reactions ◽  
Safety And Efficacy ◽  
Pharmacovigilance Database

Background: The availability of direct oral anticoagulants (DOAC) in clinical practice has transformed the health care provided to patients for the prevention and treatment of thromboembolism. Safety and efficacy data guide clinicians in the choice of the drug used. To date, no evidence is available from head-to-head trials comparing different DOAC with regard to safety and efficacy; information is mainly derived from several meta-analyses and real-life studies. Conclusions from these studies are inconsistent and unsatisfactory. The evaluation of self-reported adverse drug reactions (ADR) available from databases of drug-regulatory agencies such as the Italian Medicines Agency (AIFA) pharmacovigilance database represents a novel aid to guide decision-making. Objective: To analyze potential suspected ADR of DOAC using a previously described risk index (RI) in daily clinical practice in Italy. Methods: The National Pharmacovigilance Network database (from the AIFA website) was searched in order to retrieve information on all ADR related to oral anticoagulants occurring from 2013 to 2018. The ADR RI for each drug was calculated, where an RI = 1 indicates a balance between the percentage of ADR share and the percentage of market share for each DOAC; and an RI <1 indicates a rate of ADR lower than the rate of market share (safer DOAC). The following DOAC molecules were considered: dabigatran, rivaroxaban, apixaban, and edoxaban. Results: The results showed that rivaroxaban is the DOAC with the lowest RI among the 4 molecules available today in Italy. Conclusions: Based on the RI, we identified rivaroxaban as the DOAC having the best safety profile.

scholarly journals Using Pharmacogenetics of Direct Oral Anticoagulants to Predict Changes in Their Pharmacokinetics and the Risk of Adverse Drug Reactions

Biomedicines ◽  
2021 ◽  
Vol 9 (5) ◽  
pp. 451
Author(s):  
Natalia A. Shnayder ◽  
Marina M. Petrova ◽  
Pavel A. Shesternya ◽  
Alina V. Savinova ◽  
Elena N. Bochanova ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Genetic Information ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Genetic Knowledge ◽  
Drug Reactions ◽  
Single Nucleotide Variants ◽  
Single Nucleotide ◽  
Biotransformation Enzymes ◽  
Genes Encoding

Dabigatran, rivaroxaban, apixaban, and edoxaban are direct oral anticoagulants (DOACs) that are increasingly used worldwide. Taking into account their widespread use for the prevention of thromboembolism in cardiology, neurology, orthopedics, and coronavirus disease 2019 (COVID 19) as well as their different pharmacokinetics and pharmacogenetics dependence, it is critical to explore new opportunities for DOACs administration and predict their dosage when used as monotherapy or in combination with other drugs. In this review, we describe the details of the relative pharmacogenetics on the pharmacokinetics of DOACs as well as new data concerning the clinical characteristics that predetermine the needed dosage and the risk of adverse drug reactions (ADRs). The usefulness of genetic information before and shortly after the initiation of DOACs is also discussed. The reasons for particular attention to these issues are not only new genetic knowledge and genotyping possibilities, but also the risk of serious ADRs (primarily, gastrointestinal bleeding). Taking into account the effect of the carriership of single nucleotide variants (SNVs) of genes encoding biotransformation enzymes and DOACs metabolism, the use of these measures is important to predict changes in pharmacokinetics and the risk of ADRs in patients with a high risk of thromboembolism who receive anticoagulant therapy.

Adverse Drug Reactions and Cutaneous Manifestations Associated With Anticoagulation

2017 ◽  
Vol 21 (6) ◽  
pp. 540-550 ◽  
Author(s):  
Trang T. Vu ◽  
Melinda Gooderham
Keyword(s):  
Adverse Drug Reactions ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Accurate Diagnosis ◽  
Bleeding Complications ◽  
Thrombin Inhibitor ◽  
Drug Reactions ◽  
Cutaneous Manifestations ◽  
Systemic Drug

Anticoagulants are amongst the most commonly prescribed medications worldwide. Although rare, localised and systemic drug reactions have been reported with anticoagulants that can lead to significant morbidity and mortality. Some of the first signs of drug reactions to anticoagulants are cutaneous changes that, when recognised early, can prevent significant complications. Dermatologists should be aware of these changes to make an early and accurate diagnosis. This is particularly important in instances of skin-induced necrosis caused by systemic toxicity to anticoagulants. This review discusses adverse drug reactions to the traditional anticoagulants, warfarin and heparin, and the newer direct oral anticoagulants (DOACs) such as the thrombin inhibitor, dabigatran, and the factor Xa inhibitors, rivaroxaban, apixaban, and edoxaban. In particular, this review provides dermatologists with a framework for early diagnosis and management of patients with drug reactions to anticoagulants and alerts them to potential bleeding complications associated with minor procedures.

scholarly journals A rare case report of apixaban-induced lichenoid eruption

2020 ◽  
Vol 11 ◽  
pp. 204209862093788
Author(s):  
Tanvi Patil ◽  
Suzanne Hanna ◽  
Wayne Torre
Keyword(s):  
Adverse Drug Reactions ◽  
Case Reports ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Plain Language ◽  
Drug Reactions ◽  
Mortality And Morbidity ◽  
First Case ◽  
Post Marketing ◽  
Lichenoid Eruption

With recent increase in the use of direct oral anticoagulants (DOACs), several new cases of adverse drug reactions (ADRs) have been identified in pharmacovigilance surveys. These ADRs can result in significant mortality and morbidity if not identified and treated promptly. It is important for physicians to recognize that immunologically mediated delayed hypersensitivity reactions, although rare in occurrence, can have significant impact on patient’s quality of life. To the best of our knowledge, we report the first case of lichenoid eruption associated with apixaban. We further provide evidence of tolerance to rivaroxaban in the same patient. Plain language summary Apixaban-induced lichenoid eruption Well documented case reports, although providing evidence of probable causal relationship between a drug and specific adverse drug reactions (ADRs), can increase awareness amongst clinicians treating patients with direct oral anticoagulants (DOACs), especially with its rapid utilization. Rare ADRs are difficult to detect as clinical trials of DOACs lacked enough patient sample, making post-marketing reporting of such events important so both patients and clinicians can be vigilant to help with prompt recognition of such symptoms. We report the first case of lichenoid eruption hypersensitivity reaction associated with apixaban in patient with tolerance to rivaroxaban.

Adverse drug reactions with oral anticoagulants: data from sicilian spontaneous reporting system database

2021 ◽  
Author(s):  
Maria Antonietta Barbieri ◽  
Paola Maria Cutroneo ◽  
Chiara Baratelli ◽  
Giuseppe Cicala ◽  
Alessandro Battaglia ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Reporting System ◽  
Spontaneous Reporting System ◽  
Oral Anticoagulants ◽  
Drug Reactions ◽  
System Database

Anticoagulants: Therapeutics, Risks, and Toxicity—Special Emphasis on Heparin-Induced Thrombocytopenia (HIT)

2012 ◽  
Vol 25 (1) ◽  
pp. 22-29 ◽  
Author(s):  
James O’Donnell
Keyword(s):  
At Risk ◽  
Adverse Drug Reactions ◽  
Oral Anticoagulants ◽  
Type A ◽  
Therapeutic Use ◽  
Drug Reactions ◽  
Heparin Induced Thrombocytopenia ◽  
Novel Anticoagulants ◽  
Toxicity Risk ◽  
Life Threatening

Anticoagulants are powerful and unavoidably dangerous drugs that must be carefully selected, monitored, and evaluated. Every patient undergoing treatment is at risk of excess bleeding, since the primary purpose of this class of drugs is to decrease clotting through a variety of biochemical and pharmacological mechanisms. Under the best of circumstances, significant numbers of patients (∼10%) experience toxicity on traditional warfarin oral anticoagulants. Beyond the obvious type A pharmacological toxicity, heparin products carry a seemingly paradoxical/novel risk of increased coagulopathy with limb- and life-threatening thromboembolic injuries (heparin-induced thrombocytopenia [HIT]). As a result of the great toxicity risk, many patients suffer injuries, and litigation is threatened or initiated, frequently against pharmacists and their employers. This article reviews the therapeutic use of old and novel anticoagulants, lists the types of litigation related thereto, and discusses the HIT risk associated with heparin products treatment. Litigation can result from adverse drug reactions and toxicity from anticoagulants.

scholarly journals Epidemiological Characteristics Of Hospitalizations Due To Adverse Drug Reactions (Adrs) Relaed To Oral Anticoagulants In Spain: 2010-2013

2016 ◽  
Vol 19 (7) ◽  
pp. A470-A471
Author(s):  
P Carrasco-Garrido ◽  
A Lopez De Andres ◽  
V Hernandez Barrera ◽  
J Esteban-Hernandez ◽  
I Jimenez-Trujillo ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Oral Anticoagulants ◽  
Drug Reactions ◽  
Epidemiological Characteristics

PS-024 Monitoring of adverse drug reactions in patients treated with new oral anticoagulants

2014 ◽  
Vol 21 (Suppl 1) ◽  
pp. A153.1-A153
Author(s):  
I Freire ◽  
MO Fonseca ◽  
F Pereira ◽  
M Guardado ◽  
J Martinez
Keyword(s):  
Adverse Drug Reactions ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Drug Reactions
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