STORY FROM: Drugs & Medical Devices

Canada Regulators Say Xarelto Can Cause Bleeding in Transcatheter Aortic Valve Replacement Patients

OTTOWA, Can. — Health Canada is warning healthcare providers that, according to a recent study, Janssen Pharmaceutica’s blood thinner Xarelto (rivaroxaban) can cause thromboembolic and bleeding events in patients following transcatheter aortic valve replacement (TAVR).

In a Dec. 20 “Dear Healthcare Professional” letter, the Canadian agency says an increase in all-cause mortality, thromboembolic and bleeding events have been reported in a phase III clinical study among Xarelto-treated patients who underwent TAVR.

“In August 2018, the Data Safety Monitoring Board, while monitoring patient safety independently in the phase III clinical study (GALILEO) in patients after transcatheter aortic valve replacement (TAVR), recommended ...

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