Filtered By:
Management: Food and Drug Administration (FDA)

This page shows you your search results in order of relevance. This is page number 19.

Order by Relevance | Date

Total 621 results found since Jan 2013.

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

Survey shows half of older adults in US now taking aspirin
(Oregon State University) A national survey suggests that slightly more than half of the older adults in the United States are now taking a daily dose of aspirin, even though its use is not recommended by the Food and Drug Administration for most people who have not yet had a heart attack or stroke. The findings suggest that tens of millions of Americans have reviewed the issues involved, often discussed it with their doctors, say they know what they are doing -- and decided to use aspirin.
Source: EurekAlert! - Cancer - April 16, 2015 Category: Cancer & Oncology Source Type: news

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

PCSK9 Inhibitors and Neurocognitive Adverse Events: Exploring the FDA Directive and a Proposal for N -of-1 Trials
Abstract Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors are a novel class of medications that greatly lower low-density lipoprotein cholesterol (LDL-C) by upregulating LDL receptor availability. In early 2014, the US Food and Drug Administration (FDA) directed developers of PCSK9 inhibitors to monitor neurocognitive adverse effects and consider neurocognitive testing in at least a subset of participants in ongoing late-stage trials. Available trial evidence indicates that neurocognitive adverse events may occur more commonly in individuals receiving an antibody to PCSK9, but these events are unco...
Source: Drug Safety - May 20, 2015 Category: Drugs & Pharmacology Source Type: research

Stroke, blindness are risks of unintended injection of fillers into blood vessels
Rare but serious side effects can result when soft tissue fillers are unintentionally injected into blood vessels in the face, according to a press release from the Food and Drug Administration. Blood vessels can be blocked and blood flow restricted following unintentional soft tissue filler...
Source: Skin and Allergy News - May 28, 2015 Category: Dermatology Tags: SAN Clinical News SAN News SAN Aesthetic Dermatology Source Type: news

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

Re: Testosterone Products: Drug Safety Communication - FDA Cautions about Using Testosterone Products for Low Testosterone due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack and Stroke
U.S. Food and Drug Administration
Source: The Journal of Urology - June 17, 2015 Category: Urology & Nephrology Authors: Allen D. Seftel Tags: Urological Survey Source Type: research

Testosterone supplementation in men: a practical guide for the gynecologist and obstetrician
Purpose of review: Prescribing habits for the treatment of symptomatic hypogonadism have recently stirred controversy surrounding testosterone replacement therapy. As a result, the gynecologist will need to recognize this iatrogenic form of decreased sperm production in couples seeking fertility advice. We have compiled a review of the current literature on testosterone supplementation pertaining to the gynecologic practice. Recent findings: Over the last decade, testosterone use has seen a recent increase including in men desiring to become fathers. Many physicians and hypogonadal men do not recognize that testosterone re...
Source: Current Opinion in Obstetrics and Gynecology - July 4, 2015 Category: OBGYN Tags: REPRODUCTIVE ENDOCRINOLOGY: Edited by David L. Olive Source Type: research

FDA strengthens warning label for certain anti-inflammatory drugs
(Reuters) - The U.S. food and Drug Administration said it was strengthening an existing warning label that non-aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke.
Source: Reuters: Health - July 10, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

F.D.A. Is Set to Toughen Nonaspirin Warnings
Labels on painkillers like ibuprofen that are taken by millions of Americans will be subtly changed to say that they cause an increased risk of heart attack and stroke.
Source: NYT Health - July 10, 2015 Category: Consumer Health News Authors: SABRINA TAVERNISE Tags: Drugs (Pharmaceuticals) Food and Drug Administration Labeling and Labels (Product) Source Type: news

Experts Urge Sparing Use of Nonaspirin Painkillers
The Food and Drug Administration said it would ask drug manufacturers to change the labels to reflect evidence that nonaspirin, nonsteroidal anti-inflammatory drugs increased the risk of heart attacks and strokes.
Source: NYT Health - July 14, 2015 Category: Consumer Health News Authors: SABRINA TAVERNISE Tags: Pain-Relieving Drugs Heart Aleve (Drug) Celebrex (Drug) Drugs (Pharmaceuticals) Motrin IB Food and Drug Administration Labeling and Labels (Product) Stroke Ibuprofen (Drug) Source Type: news

The FDA Approves A Potent And Pricey Cholesterol-Lowering Shot
The Food and Drug Administration has approved Praluent, a new medicine to lower cholesterol in people who have established heart disease, for people whose risk of a heart attack or stroke is not being adequately controlled by existing drugs called statins.
Source: Forbes.com Healthcare News - July 24, 2015 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news

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

FDA Approves Expanded Indication for AstraZeneca Medications to Include Long-Term Use in Patients with a History of Heart Attack
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved BRILINTA® (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, BRILINTA is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI, also known as heart attack) and stroke in patients with acute coronary syndrome (ACS) or a history of MI.
Source: News from Angioplasty.Org - September 3, 2015 Category: Cardiology Source Type: news

Insights From Cardiovascular Outcome Trials with Novel Antidiabetes Agents: What Have We Learned? An Industry Perspective
Abstract Owing to the close association of cardiovascular (CV) disease with type 2 diabetes and the uncertainty surrounding the CV safety of antidiabetes agents, in 2008 the Food and Drug Administration issued guidance for the demonstration of CV safety for new antidiabetes drugs. Recently the results from CV outcomes trials of three dipeptidyl peptidase-4 (DPP-4) inhibitors and a glucagon-like peptide-1 receptor agonist have been reported. The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial, the Examination of Cardiovascular Outcomes with Alogliptin versus St...
Source: Current Diabetes Reports - September 14, 2015 Category: Endocrinology Source Type: research