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Condition: Atrial Fibrillation
Management: Food and Drug Administration (FDA)

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Total 197 results found since Jan 2013.

Severe jaundice due to intrahepatic cholestasis after initiating anticoagulation with rivaroxaban
Rivaroxaban, a highly selective direct factor Xa inhibitor, is a new oral anticoagulant approved by the US Food and Drug Administration in November 2011 for stroke prophylaxis in patients with nonvalvular atrial fibrillation. Because of its efficacy and once-a-day dosing, it is commonly preferred in patients with nonvalvular atrial fibrillation and intolerance to warfarin in clinical practice. However, it can result in some adverse effects such as bleeding, rashes and liver injury. Here, we described a very rare adverse reaction of rivaroxaban, jaundice due to intrahepatic cholestasis, appeared in a 71-year-old male patien...
Source: Blood Coagulation and Fibrinolysis - February 2, 2016 Category: Hematology Tags: Case Reports Source Type: research

Resolution of left ventricular thrombus with apixaban in a patient with hypertrophic cardiomyopathy.
Abstract Anticoagulation with warfarin is the main treatment of intracardiac thrombus. While novel oral anticoagulants (NOACs) have been approved by the US Food and Drug Administration (FDA) for stroke prevention in patients with nonvalvular atrial fibrillation (AF), they are not indicated for resolution of intracardiac thrombus. The case of a 60-year-old woman with left ventricular (LV) thrombus secondary to hypertrophic cardiomyopathy and AF is described in the present report. Indications for oral anticoagulation were AF and LV thrombus. Thrombus was dissolved after 1 month of apixaban treatment. To the best of ...
Source: Turk Kardiyoloji Dernegi arsivi - May 31, 2016 Category: Cardiology Authors: Kaya A, Hayıroğlu Mİ, Keskin M, Tekkeşin Aİ, Alper AT Tags: Turk Kardiyol Dern Ars Source Type: research

All bleeding stops — but does idarucizumab (Praxbind) make it stop faster?
3.5 out of 5 stars Persistent life-threatening hemorrhage after administration of idarucizumab. Alhashem HM et al. Am J Emerg Med 2016 June 30 [Epub ahead of print] Reference Dabigatran (Pradaxa) is a direct thrombin inhibitor approved for stroke and embolism prophylaxis in patients with non-valve-related atrial fibrillation. When it was first released in 2008, a major disincentive to widespread use was the lack of a reliable reversal agent to treat major bleeds, or to administer before necessary invasive procedures. In October 2015, the U.S. Food and Drug Administration approved idarucizumab (Praxbind), a monoclonal ant...
Source: The Poison Review - July 27, 2016 Category: Toxicology Authors: Leon Gussow Tags: Medical anticoagulant hemorrhage idarucizumab pradaxa praxbind reversal agent Source Type: news

Real-world US post-FDA approval usage of the Watchman device presented at TCT 2016
(Cardiovascular Research Foundation) Results from the US real-world, post-FDA approval experience of the Watchman device found high procedural success and low complication rates despite implantations by a large percentage of new operators. The Watchman device was approved by the US Food and Drug Administration in March 2015 for left atrial appendage occlusion to reduce the risk of stroke in patients with non-valvular atrial fibrillation.
Source: EurekAlert! - Medicine and Health - November 7, 2016 Category: Global & Universal Source Type: news

Edoxaban: How Does the Newest Agent Fit into the DOAC Landscape?
Edoxaban is the most recently approved factor Xa inhibitor within the class of direct oral anticoagulants (DOACs). Like other DOACs, edoxaban was approved by the US Food and Drug Administration for treatment of venous thromboembolism and prevention of stroke in patients with nonvalvular atrial fibrillation. Similar to other DOACs, edoxaban has fewer drug –drug interactions than warfarin and does not require routine laboratory monitoring. Unlike other DOACs, edoxaban has yet to be approved for secondary or postoperative venous thromboembolism thromboprophylaxis.
Source: The American Journal of Medicine - April 5, 2017 Category: General Medicine Authors: Caitlin M. Gibson, Shannon W. Finks Tags: Review Source Type: research

EWOLUTION —The next evolution in appendage closure?
Oral anticoagulation (OAC) is a class I indication for patients with nonvalvular atrial fibrillation (AF) and ≥2 risk factors for stroke.1 However, many patients with AF are ineligible for OAC because of prohibitive bleeding. Subsequently, as a result of the pivotal role of the left atrial appendage (LAA) in the formation of thrombi, an alternative strategy to OAC is occlusion of the LAA.2 The WATCHMAN de vice (Boston Scientific Corporation, Marlborough, MA) is the only US Food and Drug Administration (FDA)–approved LAA occlusion product that has been studied in randomized control trials (RCTs) (Table).
Source: Heart Rhythm - June 22, 2017 Category: Cardiology Authors: Muhammad R. Afzal, Emile G. Daoud Tags: Editorial Commentary Source Type: research

Antithrombotic Therapy in Nonvalvular Atrial Fibrillation: Consensus and Challenges.
This article discusses the advantages and disadvantages of currently approved oral antithrombotics in nonvalvular AF, with a special emphasis on the DOACs and their individual characteristics. PMID: 29753377 [PubMed - in process]
Source: The American Journal of the Medical Sciences - May 1, 2018 Category: General Medicine Authors: Khattak F, Alam MB, Paul TK, Rijal S, Wazir S, Lavie CJ, Saba S Tags: Am J Med Sci Source Type: research

Clinical Pharmacology of Oral Anticoagulants in Patients with Kidney Disease.
This article summarizes the clinical pharmacology of these drugs and identifies knowledge gaps in the literature related to their use. PMID: 29802125 [PubMed - as supplied by publisher]
Source: Clinical Journal of the American Society of Nephrology : CJASN - May 25, 2018 Category: Urology & Nephrology Authors: Jain N, Reilly RF Tags: Clin J Am Soc Nephrol Source Type: research

EP News: Allied Professionals
Using data on patients in the United States Renal Data System (USRDS), Siontis et  al (Circulation 2018; https://doi.org/10.1161/CIRCULATIONAHA.118.035418 [Epub ahead of print], PMID 29954737) sought to assess patterns of apixaban use and outcomes related to use of anticoagulants in patients with end-stage renal disease (ESRD) and atrial fibrillation (AF). As background, patient s with ESRD have both higher risk of bleeding and higher risk of stroke with AF. The Food and Drug Administration has approved updated labeling for the use of apixaban in patients with ESRD on the basis of a small pharmacokinetic study.
Source: Heart Rhythm - July 26, 2018 Category: Cardiology Authors: Erica S. Zado Tags: EP News Source Type: research

EKG, Other Heart Health Features Come to Apple Watch
NEW YORK (AP) — Apple Watch is now fulfilling its promise to let people take EKGs of their heart and notify them of any irregular heartbeat. Apple announced the heart features in September, but didn't make them available until Thursday. The new features have been given clearance by the U.S. Food and Drug Administration and are for U.S. customers only. Related JEMS Article: The iBeat Is a ‘Smart’ Watch, But It Can’t ‘Save Your Life’ The watch can intermittently check the wearer's heart rhythm in the background and send a notification if it detects irregular heart rhythm. That can point to atrial fibrillatio...
Source: JEMS Patient Care - December 7, 2018 Category: Emergency Medicine Authors: Associated Press Tags: Cardiac & Resuscitation News Source Type: news

‘We’re Not As Healthy As We Should Be.’ Fitbit CEO James Park Discusses New AFib Detection Partnership With Bristol-Myers Squibb-Pfizer
“We’re not as healthy as we should be.” That’s what Fitbit CEO and co-founder James Park said at Thursday’s TIME 100 Health Summit, where MSNBC anchor Stephanie Ruhle interviewed him about the company’s future in the health care space, the impact of wearables and just how active Fitbit’s 30 million active users really are. Ruhle talked with Park about Fitbit’s position as one of the first major wearables company to have gone public, one that led the charge in terms of mass market adoption but has lost ground to competitors offering more advanced wearable devices, as well as ...
Source: TIME: Health - October 17, 2019 Category: Consumer Health News Authors: Patrick Lucas Austin Tags: Uncategorized fitness HealthSummit19 technology Source Type: news

Oral anticoagulation in emergency department patients: high rates of off-label doses,no difference in bleeding rates
Patients with oral anticoagulation constitute an increasing proportion in the present medical routine.1 The approval of the first direct oral anticoagulant (DOAC) dabigatran by the U.S. food and drug administration in 2010 for the purpose of stroke prevention in patients with non-valvular atrial fibrillation revolutionized the therapy strategies of this entity since the Vitamin-K antagonists (VKA) warfarin, phenprocoumon and acenocoumarol had been the only available oral anticoagulants for decades.
Source: The American Journal of Medicine - October 23, 2019 Category: General Medicine Authors: Corinne M. Eschler, Bertram K. Woitok, Georg-Christian Funk, Philipp Walter, Volker Maier, Aristomenis K. Exadaktylos, Gregor Lindner Tags: Clinical Research Study Source Type: research

FDA Approves First Generics of Eliquis
December 23, 2019 -- The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation....
Source: Drugs.com - Daily MedNews - December 23, 2019 Category: General Medicine Source Type: news

FDA approves first generics of Eliquis
The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.
Source: World Pharma News - December 26, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news