Topic: Cardiovascular Medicine
US regulators on Monday ordered French pharmaceutical giant Sanofi to change the label of its heart drug Multaq after it was found to double the risk of death in some patients.Patients with permanent abnormal heart rhythm, or atrial fibrillation, should not take ...
(Reuters) - U.S. regulators on Monday revised the label for Sanofi SA's heart drug Multaq to reflect a doubling of health risks, including death, for some patients with irregular heart rhythms.In the updated label, the Food and Drug Administration said Multaq, known ...
CHICAGO (Reuters) - U.S. health regulators said they are still investigating a rare but serious problem with Boston Scientific Corp's new heart stents and required the company to caution doctors about it when the device was approved last month.The Food and Drug ...
PORTLAND, Ore (Reuters) - A 19-year-old football player at Oregon State University who collapsed while playing basketball died after suffering a cardiac arrhythmia despite having no known heart problems, officials said on Thursday.Defensive tackle Fred Thompson, a freshman listed as 6 feet ...
WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel on Thursday decided not to recommend CardioMEMS implantable heart device for treating heart failure because supporting clinical research appeared biased by human intervention.Six out of 10 members of the FDA advisory committee ...
WASHINGTON (Reuters) - U.S. health regulators on Monday said a CardioMEMs implant for treating heart failure met its main safety and effectiveness targets but warned of potential bias in the company's research.A Food and Drug Administration staff review of the CardioMEMS Champion ...
WASHINGTON (Reuters) - A Food and Drug Administration review of CardioMEMS' device for treating heart failure found it has met its main safety and effectiveness goals, based on trial results.But the FDA questioned on Monday how clinically significant the findings are for ...
NEW YORK (Reuters Health) - In a new study from a single California community, women who had been pregnant at least four times were less likely to die from cardiovascular disease than those who'd never been expecting.Researchers said that could be due ...
NEW YORK (Reuters Health) - When an elderly person's chronic disease is impossible to cure, many doctors might assume that patient would chose to improve the quality of his or her remaining life rather than to extend it as is. Those doctors ...
(Reuters) - Health regulators are investigating a rare but potentially serious problem with a newer class of heart stents that causes the tiny tubular devices made of wire mesh to shrink, or lengthen, after implantation.The problem appears to occur most frequently in ...