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 ...

FDA revises Sanofi Multaq label on heart risks

(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 ...

FDA requires precaution on Boston Sci stent

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 ...

Heart problem suspected in Oregon football player death

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 ...

FDA panel votes against CardioMEMS device

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 ...

FDA staff say CardioMEMS device works

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 ...

FDA: CardioMEMS device meets top study goals

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 ...

Lots of pregnancies linked to a healthier heart

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 ...

Heart patients prefer longevity over quality of life

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 ...

FDA sees rare but serious issue with stents

(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 ...
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