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Condition: Heart Attack
Management: Food and Drug Administration (FDA)

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Total 128 results found since Jan 2013.

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

Testosterone Drugs May Be Overused, FDA Warns
WASHINGTON (AP) — The Food and Drug Administration is warning doctors against over-prescribing testosterone-boosting drugs for men, saying the popular treatments have not been established as safe or effective for common age-related issues like low libido and fatigue. The agency says drugmakers must clearly state in their labeling and promotions that the drugs, currently taken by millions of U.S. men, are only approved to treat low testosterone levels caused by disease or injury, not normal aging. Additionally, the FDA cautioned that the drugs may increase the risk of heart attack, stroke and other cardiovascular problem...
Source: Science - The Huffington Post - March 3, 2015 Category: Science 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

Why You Should Avoid Statins
At my anti-aging clinic, I continue to wage war against what I call the “medical-industrial complex.” And I do it for one reason only – I care more about my patients than I do about profits. Big Pharma clearly takes the opposite view. And now it seems these pharmaceutical behemoths won’t be happy until every man, woman and child is popping anti-cholesterol pills. Researchers at Duke University recently issued a report recommending that even children and people as young as 30 should be on statins, if they have just slightly elevated cholesterol levels.1 And why wouldn’t researchers at Duke recommen...
Source: Al Sears, MD Natural Remedies - February 3, 2015 Category: Complementary Medicine Authors: Dr. Al Sears Tags: Heart Health Source Type: news

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

Asymptomatic Carotid Artery Stenosis Treated with Medical Therapy Alone: Temporal Trends and Implications for Risk Assessment and the Design of Future Studies
Background: The rate of adverse clinical outcomes among patients with asymptomatic carotid stenosis receiving medical therapy alone can be used to guide clinical decision-making and to inform future research. We aimed to investigate temporal changes in the incidence rate of clinical outcomes among patients with asymptomatic carotid stenosis receiving medical therapy alone and to explore the implications of these changes for the design of future comparative studies. Summary: We searched MEDLINE, the Cochrane Central Register of Controlled Trials, US Food and Drug Administration documents, and reference lists of included stu...
Source: Cerebrovascular Diseases - November 7, 2014 Category: Neurology Source Type: research

Evaluating Cardiovascular Safety of Novel Therapeutic Agents for the Treatment of Type 2 Diabetes Mellitus
Abstract Type 2 diabetes increases the risk of developing cardiovascular (CV) complications such as myocardial infarction, heart failure, stroke, peripheral vascular disease, and CV-associated mortality. Strict glycemic control in diabetics has shown improvement in microvascular complications related to diabetes but has been unable to demonstrate major effects on macrovascular complications including myocardial infarction and stroke. Conventional therapies for diabetes that include insulin, metformin, sulfonylureas (SU), and alpha-glucosidase inhibitors have limited and/or controversial data on CV safety based on...
Source: Current Cardiology Reports - October 10, 2014 Category: Cardiology Source Type: research

Keeping the Genie in the Bottle Growth Hormone and Cardiovascular Disease ∗
Anabolic hormone use is increasingly common and includes replacement in patients with hormone deficiencies, questionable uses in those with borderline-low levels, and clear abuses among athletes aiming to gain a competitive advantage. Recently, direct-to-consumer marketing touting the benefits of “low T” treatment has led to increased testosterone use among middle-aged and older men, despite inadequate cardiovascular safety data. Although the Testosterone in Older Men Trial showed improvements in strength among treated patients, it was prematurely halted due to increased cardiovascular events in the treatment arm (1). ...
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - September 29, 2014 Category: Cardiology Source Type: research

FDA says asthma drug Xolair raises risk of heart, brain problems
WASHINGTON (Reuters) - The asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday.
Source: Reuters: Health - September 26, 2014 Category: Consumer Health News Tags: healthNews Source Type: news

More Study Urged on Testosterone Drugs
A Food and Drug Administration panel recommended that makers of testosterone-replacement drugs study possible increased risks of heart attack and stroke from the hot-selling products.
Source: WSJ.com: Health - September 18, 2014 Category: Pharmaceuticals Tags: PAID Source Type: news

Dabigatran Use in the Real World: A Multihospital System Experience
Dabigatran etexilate, an oral direct thrombin inhibitor, was approved by the Food and Drug Administration to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation based on the outcomes of the Randomized Evaluation of Long-term anticoagulant therapY (RE-LY) study. Although this study provides robust data on the efficacy and safety of dabigatran, there may be differences in the drug use and outcomes in routine clinical practice following drug approval. In this retrospective chart review study, we describe the use of dabigatran in 160 patients in 4 adult hospitals (1 academic and 3 c...
Source: Journal of Pharmacy Practice - August 4, 2014 Category: Drugs & Pharmacology Authors: Kimmons, L. A., Kabra, R., Davis, M., Segars, B. V., Oliphant, C. S. Tags: Research Articles Source Type: research

Merck's Zontivity gets FDA approval to reduce heart attacks and stroke risk in patients
Merck has received approval from the US Food and Drug Administration (FDA) for Zontivity (vorapaxar) for people at high-risk of heart attack or stroke.
Source: Pharmaceutical Technology - May 13, 2014 Category: Pharmaceuticals Source Type: news

FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients
The U.S. Food and Drug Administration today approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
Source: Food and Drug Administration - May 8, 2014 Category: American Health Source Type: news

FDA against using daily aspirin to prevent a first heart attack
Alex CukanWASHINGTON, May 7 (UPI) -- The U.S. Food and Drug Administration said only those who had suffered a heart attack or stroke benefited from a low-dose daily aspirin.
Source: Health News - UPI.com - May 7, 2014 Category: Consumer Health News Source Type: news

Merck Statement on FDA Advisory Committee for Vorapaxar, Merck’s Investigational Antiplatelet Medicine
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today said it was pleased with the U.S. Food and Drug Administration (FDA)’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack. ...
Source: Merck.com - Research and Development News - January 15, 2014 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news