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Total 621 results found since Jan 2013.

Cardiac Arrest in a 21-Year-Old Man After Ingestion of 1,3-DMAA–Containing Workout Supplement
We describe a case of a young man who took such a supplement and suffered a cardiac arrest. Notably, the product consumed was not on the FDA list of substances containing DMAA. This case highlights the importance for clinicians to be aware of the potential harm of the DMAA-containing products by maintaining a high index of suspicion in otherwise healthy individuals presenting with cardiac arrest. It is of particular importance to sports medicine physicians who are most involved in education and counseling of patients potentially at risk of taking such products.
Source: Clinical Journal of Sport Medicine - December 31, 2014 Category: Sports Medicine Tags: Case Report Source Type: research

Medtronic Drug-Coated Balloon Receives FDA Approval For Treating Peripheral Artery Disease In Upper Leg
Medtronic, Inc. announced recently that the U.S. Food and Drug Administration (FDA) has approved the company's IN.PACT Admiral drug-coated balloon (DCB) for the interventional treatment of peripheral artery disease (PAD) in the upper leg, a serious and common cardiovascular condition that causes pain in the legs and is known to be associated with a four- to five-fold increase in risk for heart attack and stroke.
Source: Medical Design Online News - January 6, 2015 Category: Medical Equipment Source Type: news

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

Presentation on US Hospital Websites of Risks and Benefits of Transcatheter Aortic Valve Replacement Procedures
Adequate presentation of risks and benefits of medical therapies is essential to informed decision making by patients. Transcatheter aortic valve replacement (TAVR) has been recently approved by the US Food and Drug Administration for the treatment of severe aortic stenosis among carefully selected patients; recent randomized clinical trials have identified important positive and negative outcomes of TAVR in these populations, including twice the risk of stroke for patients undergoing TAVR vs those undergoing open aortic valve replacement. Since 78% of all adults in the United States seek out health information online, we ...
Source: JAMA Internal Medicine - January 12, 2015 Category: Internal Medicine Source Type: research

Epidural Steroid Injections are Safe and Effective: Multisociety Letter in Support of the Safety and Effectiveness of Epidural Steroid Injections
Abstract Background: In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. Results: The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multiso...
Source: Pain Medicine - January 13, 2015 Category: Anesthesiology Authors: , David J. Kennedy, Joshua Levin, Richard Rosenquist, Virtaj Singh, Clark Smith, Milan Stojanovic, Yakov Vorobeychik Tags: Other Source Type: research

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

FDA clears system to reduce stroke risk during stent and angioplasty procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.
Source: Food and Drug Administration - February 9, 2015 Category: American Health Source Type: news

FDA clears device for reducing stroke risk
The U.S. Food and Drug Administration has cleared a device designed to reduce (more)
Source: AuntMinnie.com Headlines - February 9, 2015 Category: Radiology Source Type: news

Aspirin use in women for primary prevention
At present, there is no consensus on antiplatelet treatments in primary prevention, particularly for women. European guidelines on cardiovascular disease (CVD) prevention1 do not recommend antiplatelet therapy, while the American Heart Association guidelines for primary prevention2 support a daily treatment of low-dose aspirin in women aged >65 years. The US Food and Drug Administration at the beginning of this year stated that the agency "does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of ...
Source: Heart - February 12, 2015 Category: Cardiology Authors: Ferrario, M. M., Veronesi, G. Tags: Press releases, Drugs: cardiovascular system, Acute coronary syndromes, Epidemiology Editorials Source Type: research

Testosterone replacement products boost heart attack, stroke risk, FDA says
The Food and Drug Administration has ordered the makers of testosterone replacement products, which have been aggressively marketed to men with symptoms of low energy and libido, to bear a warning that there is a "possible increased risk of heart attack and strokes" in patients taking the...
Source: Los Angeles Times - Science - March 4, 2015 Category: Science Source Type: news

Drugs Using Testosterone Will Label Heart Risks
The F.D.A. ordered that labels on testosterone drugs warn of heart attack and stroke risks, and advised that the drugs should not be prescribed to treat symptoms in men brought on by age, such as declining sexual drive.
Source: NYT Health - March 4, 2015 Category: Consumer Health News Authors: By SABRINA TAVERNISE Tags: Drugs (Pharmaceuticals) Food and Drug Administration Labeling and Labels Testosterone Source Type: news

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