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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 the drug -- also known as dronedarone -- because of a two-fold higher rate of cardiovascular death, stroke, and ...
(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 chemically as dronedarone, should not be used by patients who have permanent atrial fibrillation (AF), a ...
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 Administration approved the Boston Scientific Promus Element heart stent -- a tiny tubular device used to prop ...
NEW YORK (Reuters Health) - One New Orleans hospital saw a jump in heart attacks following Hurricane Katrina -- and three years later, the rate was still elevated, a new study finds.
Researchers at Tulane University Hospital found that over the three years following the 2005 hurricane, 2 percent of patient admissions were for heart attack. That compared with 0.7 percent ...
ADELPHI, Maryland (Reuters) - U.S. drug advisers recommended that the label for Johnson and Johnson's Ortho Evra birth control patch be simplified to better explain the risk of blood clots.
In a 20 to 3 vote with one abstention, advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women ...
A panel of experts that advises the US Food and Drug Administration has urged stronger labeling on birth control pills such as Bayer's Yaz that have a shown a higher risk of blot clots.
Results of the 21-5 vote released late Thursday showed that most panel members found the current labels did not adequately reflect the risks and benefits ...
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 4 inches and 317 pounds, went down at the school's recreation center on Wednesday evening and was ...
ADELPHI, Maryland (Reuters) - U.S. health advisers recommended a revision of labels for the widely used new generation of birth control pills, based on data showing they may put women at a higher risk of dangerous blood clots.
Although all common birth control pills increase women's chances of getting blood clots, concerns have recently been mounting about an even ...
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 of outside experts said they could not determine whether the potential benefits of the wireless pressure sensor ...
ADELPHI, Maryland (Reuters) - U.S. health advisers recommended a revision of labels for the widely used new generation of birth control pills, based on data showing they may put women at a higher risk of dangerous blood clots.
Although all common birth control pills increase women's chances of getting blood clots, concerns have recently been mounting about an even ...
