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J&J and Bayer Aim to Expand XARELTO Indication Despite Current Health Risks

Johnson & Johnson and Bayer’s Xarelto is already in the lead of the new generation of anticoagulants.  Recently, the drugmakers made known that they are looking to expand that market lead with new clinical trials aimed at widening the drug’s label.

Xarelto has been the focus of widespread attention with lawyers signing cases where patients suffered bleeding events.  Pradaxa, a similar anticoagulant, was the focus of numerous lawsuits which ultimately resulted in settlement.  Drug companies of these new-age drugs use as a major selling point that routine check-ups are not needed, compared to users of Coumadin (Warfarin Sodium).  While Coumadin still remains the gold standard when it comes to anticoagulants, more and more doctors are turning to Xarelto and others.  But unlike Coumadin, there is no antidote to stop bleeding.  This presents serious dangers to patients especially, for instance, if a patient undergoes a brain hemorrhage.

J&J and Bayer intend on building out their cardiovascular research program to test Xarelto as a treatment for acute coronary syndrome (ACS), embolic stroke of undetermined source and peripheral artery disease.  An ACS approval would be money-spinning for the drugmakers, with the malady accounting for some 1.1 million hospital admissions annually in the U.S.  Yet three separate times, the FDA has rejected their application for an expanded ACS indication.  Even without these expanded indications, in this year’s second quarter, Xarelto therapy nearly doubled its U.S. top-line haul from the year-ago period to $361 million.

Claudine Q. Homolash, Esquire, founder of the CQH Firm, is a whistleblower, pharmaceutical injury and personal injury lawyer representing clients nationwide. She can be contacted at or (844) 677-4276 or (215) 496-1012 for a free legal consultation.

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