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Specialty: Consumer Health News
Management: Food and Drug Administration (FDA)

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Total 55 results found since Jan 2013.

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

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

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

FDA panel offers mixed view on Boston Scientific Watchman device
WASHINGTON (Reuters) - An advisory panel to the U.S. Food and Drug Administration offered a mixed view of Boston Scientific Corp's Watchman heart device on Wednesday, concluding it is probably safe but not particularly effective in reducing the risk of stroke in patients with a certain type of irregular heart beat.
Source: Reuters: Health - October 8, 2014 Category: Consumer Health News Tags: healthNews Source Type: news

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

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

FDA looks again at Boston Scientific anti-stroke device
(Reuters) - U.S. Food and Drug Administration staff reviewing data on Boston Scientific Corp's novel anti-stroke device highlighted the implant's failure to meet a key goal for effectiveness in a recent study but said on Monday that other data must be weighed in deciding whether it should be approved.
Source: Reuters: Health - December 9, 2013 Category: Consumer Health News Tags: healthNews Source Type: news

FDA says new cholesterol drugs may not need outcome studies
(Reuters) - Members of an experimental class of cholesterol-lowering drugs could get U.S. regulatory approval based on their ability to lower "bad" cholesterol, and may not need to show that they reduce the risk of heart attack and stroke, the Food and Drug Administration said on Thursday.
Source: Reuters: Health - November 15, 2013 Category: Consumer Health News Tags: healthNews Source Type: news

Different risks for heart attack and stroke posed by different hormone therapy formulations
Post-menopausal women whose doctors prescribe hormone replacement therapy for severe hot flashes and other menopause symptoms may want to consider taking low doses of Food and Drug Administration-approved bioidentical forms of estrogen or getting their hormones via a transdermal patch. A new observational study shows bioidentical hormones in transdermal patches may be associated with a lower risk of heart attack and FDA-approved products -- not compounded hormones -- may be associated with a slightly lower risk of stroke compared to synthetic hormones in pill form...
Source: Health News from Medical News Today - September 20, 2013 Category: Consumer Health News Tags: Menopause Source Type: news

Study Of Brain Cooling And Clot-Busting Drug Therapy For Stroke Receives FDA OK To Expand
An international multicenter clinical trial led by a Cedars-Sinai neurologist on the combination of brain cooling and "clot-busting" drug therapy after stroke has received Food and Drug Administration approval to expand from 50 patients to 400. � "This approval is highly significant because, after reviewing our initial safety data, the Food and Drug Administration approved us to include more patients in our study," said Patrick D. Lyden, MD, chair of the Department of Neurology at Cedars-Sinai Medical Center and the study's overall principal investigator...
Source: Health News from Medical News Today - February 8, 2013 Category: Consumer Health News Tags: Stroke Source Type: news