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

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Total 197 results found since Jan 2013.

The New Era of Anticoagulation
This article reviews the literature on these novel anticoagulants, including their pharmacokinetics and treatment indications.
Source: Annals of Vascular Surgery - January 10, 2014 Category: Surgery Authors: Nedaa Skeik, Kyle K. Rumery, Gabriel T. Rodriguez Tags: General Review Source Type: research

Reply Regarding the Effect of Dabigatran Plasma Concentrations
We would like to respond to Dr. Rao's questions concerning our paper (1). First, it is incorrect to state that any data on dabigatran and plasma levels were suppressed. This information has been submitted to all regulatory authorities as part of the original registration process of dabigatran etexilate for reduction of stroke in patients with atrial fibrillation. These data have also been in the public domain since the U.S. Food and Drug Administration (FDA) Advisory Committee meeting in September 2010, before marketing approval (2).
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - June 23, 2014 Category: Cardiology Source Type: research

FDA panel backs Daiichi's blood thinner
(Reuters) - A panel of advisers to the U.S. Food and Drug Administration voted 9-1 in favor of approving Japanese drugmaker Daiichi Sankyo Co's blood clot and stroke preventer for use in some patients with atrial fibrillation.
Source: Reuters: Health - October 30, 2014 Category: Consumer Health News Tags: healthNews Source Type: news

Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN™ Left Atrial Appendage Closure Therapy
The WATCHMAN (Boston Scientific Corp, Maple Grove, MN) left atrial appendage closure (LAAC) technology is a percutaneously delivered permanent cardiac implant placed in the LAA. This device is designed to reduce the risk of stroke and systemic embolism in warfarin-eligible patients with non-valvular atrial fibrillation. The first circulatory system device panel reviewed the Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF) study in 2009, and a “Not Approvable” letter was issued by the US Food and Drug Administration (FDA) based on safety concerns.
Source: The American Journal of Cardiology - November 11, 2014 Category: Cardiology Authors: Ron Waksman, Lakshmana K. Pendyala Source Type: research

Dabigatran: a new chapter in anticoagulation.
Authors: Ahmed S, Levin V, Malacoff R, Martinez MW Abstract For the last 60 years warfarin has been the cornerstone for chronic anticoagulation in prevention of ischemic strokes and systemic embolization. Warfarin therapy has several limitations including frequent monitoring and various food and significant drug interactions, which make it a less than ideal chronic oral anticoagulant. The continued search for safe, effective, medications with predictable pharmacokinetic profiles has led to newer alternatives. Dabigatran is a potent reversible, competitive direct thrombin inhibitor which is available as the prodrug,...
Source: Cardiovascular and Hematological Agents in Medicinal Chemistry - November 23, 2014 Category: Cardiology Tags: Cardiovasc Hematol Agents Med Chem Source Type: research

Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN Left Atrial Appendage Closure Therapy
The WATCHMAN left atrial appendage closure (LAAC) technology is a percutaneously delivered permanent cardiac implant placed in the LAA. This device is designed to reduce the risk of stroke and systemic embolism in warfarin-eligible patients with nonvalvular atrial fibrillation. The first circulatory system device panel reviewed the Embolic Protection in Patients With Atrial Fibrillation (PROTECT AF) study in 2009, and a “not approvable” letter was issued by the US Food and Drug Administration (FDA) based on safety concerns.
Source: The American Journal of Cardiology - November 11, 2014 Category: Cardiology Authors: Ron Waksman, Lakshmana K. Pendyala Tags: Review Source Type: research

FDA approves anti-clotting drug Savaysa
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
Source: Food and Drug Administration - January 8, 2015 Category: American Health Source Type: news

Recent Advances in the Development of Specific Antidotes for Target‐Specific Oral Anticoagulants
Warfarin, a vitamin K antagonist, has been the only orally available anticoagulant for > 60 years. During the past decade, the U.S. Food and Drug Administration has approved several target‐specific oral anticoagulants (TSOACs) for the prophylaxis and treatment of arterial and venous thromboembolism and stroke prevention in patients with nonvalvular atrial fibrillation. These new agents have several advantages over warfarin including more predictable pharmacokinetics and pharmacodynamics, fewer food and drug interactions, and lack of need for routine coagulation monitoring. However, unlike warfarin, currently no ant...
Source: Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy - February 3, 2015 Category: Drugs & Pharmacology Authors: Yoonsun Mo, Felix K. Yam Tags: Review of Therapeutics Source Type: research

Boston Scientific gets U.S. OK for Watchman heart device
(Reuters) - Boston Scientific Corp said on Friday that the U.S. Food and Drug Administration approved its device to prevent stroke in patients with a dangerous irregular heart rhythm known as atrial fibrillation (AF).
Source: Reuters: Health - March 13, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

Novel Oral Anticoagulants (NOAC) and Reversal Agents: Considerations for Clinical Development
This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.
Source: American Heart Journal - April 3, 2015 Category: Cardiology Source Type: research

Novel oral anticoagulants and reversal agents: Considerations for clinical development
This article reflects the views of the authors and should not be construed to represent FDA's views or policies.
Source: American Heart Journal - April 8, 2015 Category: Cardiology Source Type: research

The new oral anticoagulants: clinical use and reversal agent development
Warfarin has been the centre of oral anticoagulant therapy for over 60 years. Recent development of new oral anticoagulants (NOACs) has provided a safe and effective alternative for stroke prevention in patients with atrial fibrillation and for prevention of venous thromboembolism. Determination of their use in acute coronary syndrome has been hampered by increases in bleeding events in most large trials, especially when used with antiplatelet therapy. NOACs have equal or superior efficacy and safety profiles compared to warfarin, fewer drug interactions; no dietary restrictions; predictable responses that eliminates moni...
Source: ISBT Science Series - April 13, 2015 Category: Hematology Authors: J. Costin, J. Ansell, S. Bakhru, B. Laulicht, S. Steiner Tags: Invited Review Source Type: research

Reply
We appreciate the interest in our article, “Overview of the Food and Drug Administration Circulatory System Devices Panel Meetings on WATCHMAN Left Atrial Appendage Closure Therapy,” and that it stimulated provocative discussion in a letter to the editor. First, the WATCHMAN device was approved with the indication to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation, who are at an increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores; are deemed by their physicians to be suitable for warfarin; and have an appropriat...
Source: The American Journal of Cardiology - April 23, 2015 Category: Cardiology Authors: Ron Waksman Source Type: research

Atrial Fibrillation and Renal Function How High Is the Price of Anticoagulation? ∗
For over a half century, vitamin K antagonists, chiefly warfarin, were the exclusive oral anticoagulants available for long-term anticoagulation. Being “the only game in town,” the emphasis of the accompanying clinical research was focused on determining the most appropriate method to measure anticoagulant effects, define the most efficacious and safe target range for anticoagulation, and identify strategies to maintain and reverse therapeutic anticoagulation. This emphasis came at the expense of turning a blind eye to rare concerns raised about the potential for warfarin to cause or worsen renal dysfunction (1,2). Th...
Source: Journal of the American College of Cardiology - June 8, 2015 Category: Cardiology Source Type: research

Cardiovascular safety of albiglutide in the Harmony programme: a meta-analysis
Publication date: Available online 11 August 2015 Source:The Lancet Diabetes & Endocrinology Author(s): Miles Fisher, Mark C Petrie, Philip D Ambery, Jill Donaldson, John J V McMurray, June Ye Background Albiglutide is a glucagon-like peptide-1 receptor agonist, a new class of drugs used to treat type 2 diabetes. We did a prospective meta-analysis of the cardiovascular safety of albiglutide as stipulated by the US Food and Drug Administration recommendations for the assessment of new treatments for diabetes. Methods We did a meta-analysis of eight phase 3 trials and one phase 2b trial in which patients wer...
Source: The Lancet Diabetes and Endocrinology - August 12, 2015 Category: Endocrinology Source Type: research