Topic: Food and Drug Administration
US regulators said Tuesday that Xarelto, a Bayer-made drug approved in July for preventing blood clots, is so far unproven for a new proposed use as a stroke preventer."There is a lack of substantial evidence that rivaroxaban will have its desired effect ...
GAITHERSBURG, Maryland (Reuters) - Edwards Lifesciences Corp's heart valve for patients deemed too sick to have open-heart surgery was approved by a Food and Drug Administration advisory panel on Wednesday, despite concerns that it could increase the risk of stroke.After deliberating on ...
WASHINGTON (Reuters) - Drug reviewers said Edwards Lifesciences' heart valve "demonstrated superiority" in a trial that also showed the device's safety and effectiveness for patients considered too sick to have open-heart surgery.The trial, however, also showed people were at a high risk ...
WASHINGTON (Reuters) - Pfizer's drug to help smokers quit, which has already been linked to psychiatric side effects, can lead to a small increase in heart problems in those who have cardiovascular disease, U.S. health regulators said on Thursday.The Food and Drug ...
An advisory panel for the US Food and Drug Administration will meet next month to review a new type of heart valve that is inserted by catheter instead of in open heart surgery, the device-maker said Tuesday.The FDA committee of experts is ...
The US Food and Drug Administration said Tuesday it is reviewing recently published studies which have pointed to an increased blood clot risk associated with a certain type of birth control pill.The studies involve pills that contain drospirenone, as opposed to another ...
LONDON (Reuters) - The U.S. drugs regulator said it was not recommending changes in the use of stimulants such as Adderall XR and Ritalin to treat hyperactivity, after a review of a study into potential heart disease risks from the drugs."At this ...
CHICAGO (Reuters) - A U.S.-based unit of Terumo Corp said it has entered into a consent decree with the U.S. Food and Drug Administration and agreed to stop selling two of its products used in cardiopulmonary bypass surgery.The consent decree stems from ...
US studies on risky heart devices are skewed toward men and do not include enough women to accurately judge how they may affect the sexes differently, researchers said Tuesday.The under-representation of women is concerning because heart disease affects women in different ways ...
NEW YORK (Reuters Life!) - Many heart devices are approved for use in the United States despite a lack of data on safety and effectiveness for women -- even though the devices don't work the same in the two genders, according to ...
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Star Scientific-Smokeless Tobacco
FILE - In this Sept. 28, 2010 file photo, smokeless tobacco products, including ...AP News - -
FDA Obesity Treatments
In this product photograph provided by Allergan, Inc., the LAP-BAND System is ...AP News - -
Congress Food Safety
FILE - In this Oct. 25, 2010 file photo, Sen. Tom Harkin, D-Iowa ...AP News -
From Around the Web
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The FDA's New and Improved ...
The US Food and Drug Administration recently unveiled nine graphic ...2011-08-02 -
FDA Disputes TV Suggestion of Apple ...
The federal Food and Drug Administration and toxicologists are disputing ...2011-09-15 -
Dr. Mercola Discusses the FDA
articles.mercola.com Natural health physician and Mercola.com founder ...2011-09-11
