Topic: Food and Drug Administration
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
WASHINGTON (Reuters) - Health officials are weighing stricter labels on 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.U.S. Food and Drug Administration staff reviewed studies ...
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 ...