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FDA axes expansion of Xarelto for third time

March 27th, 2015

The U.S. Food and Drug Administration (FDA) has denied expanding the use of anticoagulant Xarelto for the third time, according to the Wall Street Journal. In February 2014, the FDA advisory panel noted that a significant amount of information was missing from a Xarelto study, making the information flawed and unreliable.

Xarelto’s manufacturers Johnson & Johnson and Bayer AG attempted to have Xarelto expanded for use in patients who suffered heart attacks or other complications due to acute coronary syndrome (ACS) three times since 2011. Currently, the blood thinning drug is only approved to prevent deep vein thrombosis, blood clots and pulmonary embolism in patients with irregular heartbeats.

Bayer and J&J face thousands of Xarelto lawsuits alleging that the drug caused severe side effects, including blood clots, heart attack and stroke. More than 1,800 adverse events have been associated with the drug, including 183 Xarelto deaths.

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