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Total 128 results found since Jan 2013.

Reversing the effects of the new anti-clotting drugs
The oral anticoagulant warfarin (Coumadin) became available for prescription in 1954. This anti-clotting drug commanded national attention when President Dwight Eisenhower received the drug as part of his treatment following a heart attack. No other oral anticoagulant was successfully developed and marketed in the United States until 2010. Warfarin is a dangerous drug. Along with insulin, it is responsible for the most emergency hospitalizations due to adverse drug reactions. Whereas insulin causes low blood sugar, warfarin is notorious for the complication of major bleeding. Warfarin is plagued by hundreds of drug-drug an...
Source: New Harvard Health Information - December 9, 2015 Category: Consumer Health News Authors: Samuel Z. Goldhaber, MD Tags: Drugs and Supplements Health Heart Health Hypertension and Stroke anti-clotting coumadin deep-vein-thrombosis DVT Source Type: news

An Update on the Cardiovascular Risks Associated With NSAIDs
Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used medications for osteoarthritis, rheumatoid arthritis, and myalgias (Table 1). In 2005, the United States Food and Drug Administration (FDA) placed a black box warning in the prescribing information of NSAIDs for the risk of myocardial infarction (MI) and stroke associated with their use.1 Last year, the FDA met to discuss new literature on NSAID cardiovascular (CV) risk to determine how it would affect prescription labeling.2 There were several observational studies and meta-analyses reviewed.
Source: The Journal for Nurse Practitioners - October 31, 2015 Category: Nursing Authors: Jason Babby, Archna Lall Tags: Prescription Pad Source Type: research

Is platelet transfusion the solution to reverse platelet inhibition in patients on triple antiplatelet therapy?
Antiplatelet therapy is the cornerstone of secondary prevention against acute thrombotic events in patients with cardiovascular disease [1]. Health Organizations around the world recommend combination therapy with aspirin and a P2Y12 receptor inhibitor for up to one year following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), and lifelong aspirin therapy thereafter [2]. Vorapaxar, a first-in-class novel protease-activated receptor (PAR)-1 antagonist, was approved in addition to standard antiplatelet therapy, to further reduce the risk of myocardial infarction (MI), stroke, cardiovascular dea...
Source: Thrombosis Research - October 30, 2015 Category: Hematology Authors: Marie Lordkipanidzé Source Type: research

Get the flu vaccine, reduce your risk of death
Last year was a lousy year for the flu vaccine. Hospitalizations for flu hit a nine-year high, and the vaccine prevented flu in only 23% of all recipients, compared with 50% to 60% of recipients in prior years. Why does the flu vaccine work well in some winters and not others? The flu vaccine primes the immune system to attack two proteins on the surface of the influenza A virus, hemagglutinin (H) and neuraminidase (N). Different flu strains have different combinations of these proteins — for example, the strains targeted by recent flu vaccines are H3N2 and H1N1. Unfortunately, the influenza virus is microbiology’s ans...
Source: New Harvard Health Information - September 15, 2015 Category: Consumer Health News Authors: John Ross, MD, FIDSA Tags: Cold and Flu Vaccines Flu Shot flu vaccine 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

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

FDA Issues New Heart Attack, Stroke Risk Warnings for NSAIDs
The Food and Drug Administration has taken new action to strengthen existing warning labels about the increased risk of heart attack or stroke with the use of prescription and over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs.
Source: Caring for the Ages - August 29, 2015 Category: Health Management Authors: Jeff Evans 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

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

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

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

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

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

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