scholarly journals Off-Label Use of Non-Vitamin K Antagonist Oral Anticoagulants

2017 ◽  
Vol 69 (20) ◽  
pp. 2577-2578
Author(s):  
Stijn P.G. van Vugt ◽  
Marc A. Brouwer ◽  
Freek W.A. Verheugt
Keyword(s):  
Vitamin K ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals International Survey for Strategies Used for Oral Anticoagulation Reversal in Children

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4976-4976
Author(s):  
Shveta Gupta ◽  
Ayesha Zia ◽  
Ravindra Sarode
Keyword(s):  
Board Of Directors ◽  
Vitamin K ◽  
Major Bleeding ◽  
Online Survey ◽  
Pediatric Population ◽  
Oral Anticoagulants ◽  
Off Label Use ◽  
Advisory Committees ◽  
Off Label ◽  
Label Use

Background: Vitamin K antagonists (VKA) have been the main stay of oral anticoagulation (OAC) in pediatrics. However, VKA have multiple challenges. The pharmacological properties of direct oral anticoagulants (DOACs) suggest that they may have advantages particularly for children. The off-label use of DOACs is however on the rise within the pediatric population. The increasingly broad and varied use of DOACs, lack of published clinical guidance, and limited data on reversal strategies have created the imperative to identify strategies for OAC reversal in pediatrics. We conducted an online survey for strategies used for oral anticoagulants reversal in pediatrics. Study Design: Institutional review board approval was obtained and an online survey was developed using the RedCap. The survey was electronically distributed by International Society of Hemostasis and Thrombosis (ISTH) to its Pediatric/Neonatal Thrombosis and Hemostasis Subcommittee group members. The survey questions asked approach to common hypothetical clinical scenarios for OAC reversal.The data were analysed descriptively. Results: There were 76 respondents, majority from academic free-standing Children'sHospitals. Seventy-two percent reported having a hemostasis-thrombosis/anticoagulation service but only 29 % have a dedicated anticoagulation pharmacist. Approximately 40% do not have a formal protocol in place for VKA reversal. For a supra-therapeutic INR (INR > 5) in a non-bleeding patient, 95% opted to manage by omitting the next dose of VKA while 18 % opted to give oral vitamin K alone or comitantly. For clinically relevant non-major bleeding, majority indicated using Vitamin K; oral (51%) or IV (37). For major bleeding on VKA, majority use either a combination of 4F-PCC and IV Vitamin K or plasma and IV Vitamin K (44/76 and 26/76 respectively). The presence of bleeding seemed to be the major driver for the choice of route (enteral versus parenteral) for Vitamin K for VKA reversal. Thirty-six of the 76 respondents indicated using DOACs; 94% used FXa inhibitors and 1/3 use dabigatran in their clinical practice. For non-urgent DOAC reversal, 97% indicated omitting the next dose. For non-major bleeding on DOAC, majority (29/36) indicated omitting the next dose/doses, some chose 4F-PCC (8/36) and only a few indicated use of specific reversal agents (3/36 and 1/36 for Dabigatran and Andexanet respectively). For major bleeding while on DOACs, the use of specific reversal agents (11/35, 6/35 for Andexanet and idarucizumab respectively) followed by 4F-PCC (9/35) was the major intervention indicated. Dilute thrombin time and partial thromboplastin time were the most commonly utilized tests to measure residual dabigatran activity. For Factor Xa inhibitors routine heparin assay rather than DOAC calibrated anti-Xa activity is utilized by most of the responders to assess presence of the plasma drug activity. Conclusion: Practices for oral anticoagulants reversal vary substantially in the pediatric population. Plasma is still used for urgent VKA reversal in many pediatric centers. The off-label use of DOACs in children is on the rise. Our results highlight the need for further studies to standardize OAC reversal in children. Disclosures Gupta: Novo Nordisk: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda-Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; CSL Behring: Research Funding; Novartis: Honoraria, Speakers Bureau; Octapharma: Honoraria, Membership on an entity's Board of Directors or advisory committees. Sarode:Portola: Honoraria; Octaphrarma: Consultancy; CSL Behring: Consultancy; Siemens: Research Funding. OffLabel Disclosure: The pharmacological properties of direct oral anticoagulants (DOACs) suggest that they may have advantages particularly for children. They are currently not approved in children. The off-label use of DOACs is however on the rise within the pediatric population.

scholarly journals Off-Label Use of New Oral Anticoagulants

Stroke ◽  
2014 ◽  
Vol 45 (7) ◽  
pp. 2158-2159
Author(s):  
Carlos A. Molina ◽  
Magdy H. Selim
Keyword(s):  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

scholarly journals Off-Label Dosing of Non-Vitamin K Antagonist Oral Anticoagulants and Adverse Outcomes

2016 ◽  
Vol 68 (24) ◽  
pp. 2597-2604 ◽  
Author(s):  
Benjamin A. Steinberg ◽  
Peter Shrader ◽  
Laine Thomas ◽  
Jack Ansell ◽  
Gregg C. Fonarow ◽  
...  
Keyword(s):  
Vitamin K ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Adverse Outcomes ◽  
Off Label

scholarly journals Off-label Use of Direct Oral Anticoagulants in Patients Receiving Surgical Mechanical and Bioprosthetic Heart Valves

2021 ◽  
Vol 4 (3) ◽  
pp. e211259
Author(s):  
Ankur Kalra ◽  
Sajjad Raza ◽  
Baqir Hasan Jafry ◽  
Harley E. King ◽  
Joseph A. Lahorra ◽  
...  
Keyword(s):  
Heart Valves ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label Use ◽  
Bioprosthetic Heart Valves ◽  
Off Label ◽  
Label Use

Off-label dosing of non–vitamin K antagonist oral anticoagulants and clinical outcomes in Asian patients with atrial fibrillation

Heart Rhythm ◽  
2020 ◽  
Vol 17 (12) ◽  
pp. 2102-2110
Author(s):  
Yi-Hsin Chan ◽  
Tze-Fan Chao ◽  
Shao-Wei Chen ◽  
Hsin-Fu Lee ◽  
Yung-Hsin Yeh ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Outcomes ◽  
Vitamin K ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Off Label ◽  
Asian Patients

scholarly journals Off-label Use of Direct Oral Anticoagulants Compared With Warfarin for Left Ventricular Thrombi

2020 ◽  
Vol 5 (6) ◽  
pp. 685 ◽  
Author(s):  
Austin A. Robinson ◽  
Cory R. Trankle ◽  
Grayson Eubanks ◽  
Christopher Schumann ◽  
Paul Thompson ◽  
...  
Keyword(s):  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Left Ventricular ◽  
Off Label Use ◽  
Off Label ◽  
Left Ventricular Thrombi ◽  
Label Use

scholarly journals Off-Label Use of Direct Oral Anticoagulants in Intracerebral Hemorrhage Patients With Prosthetic Valves

Stroke ◽  
2017 ◽  
Vol 48 (11) ◽  
pp. 3183-3186
Author(s):  
Seemant Chaturvedi ◽  
Carlos A. Molina ◽  
Magdy H. Selim ◽  
Hans-Christoph Diener ◽  
Stefan H. Hohnloser
Keyword(s):  
Intracerebral Hemorrhage ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Off Label Use ◽  
Off Label ◽  
Prosthetic Valves ◽  
Label Use

scholarly journals Off-Label Underdosing or Overdosing of Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation: A Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Xiaojuan Wu ◽  
Linyan Hu ◽  
Jinjin Liu ◽  
Qiuping Gu
Keyword(s):  
Myocardial Infarction ◽  
Atrial Fibrillation ◽  
Gastrointestinal Bleeding ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Vitamin K Antagonist ◽  
Systemic Embolism ◽  
Off Label ◽  
Label Dose

Background: Several studies have investigated the role of off-label non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF). We aimed to compare the effectiveness and safety outcomes between off-label underdose or overdose vs. on-label dose of NOACs in AF patients.Methods: The PubMed database was systematically searched until August 2021. Observational cohorts were included if they compared the outcomes of off-label underdose or overdose with on-label dose of NOACs in AF patients. The risk ratios (RRs) and 95% confidence intervals (CIs) were pooled using a fixed-effects model (I2 ≤ 50%) or a random-effects model (I2 > 50%).Results: A total of 15 observational studies were included. Compared with on-label dose of NOACs, off-label underdose of NOACs was associated with increased risks of stroke or systemic embolism (RR = 1.09, 95% CI 1.02–1.16), and all-cause death (RR = 1.29, 95% CI 1.10–1.52) but not ischemic stroke (RR = 1.34, 95% CI 0.76–2.36), myocardial infarction (RR = 1.08, 95% CI 0.92–1.28), major bleeding (RR = 0.97, 95% CI 0.89–1.05), intracranial hemorrhage (RR = 1.12, 95% CI 0.90–1.40), and gastrointestinal bleeding (RR = 0.96, 95% CI 0.85–1.07), whereas off-label overdose of NOACs was associated with increased risks of SSE (RR = 1.20, 95% CI 1.05–1.36), all-cause death (RR = 1.22, 95% CI 1.06–1.39), and major bleeding (RR = 1.33, 95% CI 1.16–1.52) but not gastrointestinal bleeding (RR = 1.18, 95% CI 0.99–1.42) and myocardial infarction (RR = 0.98, 95% CI 0.75–1.30).Conclusion: Compared with on-label dose of NOACs, off-label underdose was associated with increased risks of stroke or systemic embolism and all-cause death, whereas off-label overdose of NOACs was associated with increased risks of stroke or systemic embolism, all-cause death, and major bleeding.

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