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New BMJ Study Suggests Xarelto Use Doubles Gastrointestinal Bleeding Risk

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The popular blood thinner Xarelto may be the leading blood thinner in its class in the U.S., but a recent study published in the British Medical Journal suggests that use of rivaroxaban (the generic name for Xarelto) may double the risk for gastrointestinal bleeding when compared with warfarin (the generic version of Coumadin).

The study, which focused on over 45,000 U.S. patients, was intended to help determine the overall safety of rivaroxaban when compared with warfarin in terms of the risk of gastrointestinal bleeding as a side effect, but the researchers were unable to rule out a bleeding risk of more than twice that of warfarin.

Xarelto Prescribed to Prevent Blood Clots

Anticoagulants like Xarelto are widely prescribed in the U.S. and around the world to prevent blood clots from forming due to atrial fibrillation or after hip or knee replacement surgery. They are also used to treat deep vein thrombosis (DVT) and to prevent blood clots from forming again.

Although Xarelto offers several distinct advantages over warfarin, including simplified dosing, no monitoring requirement, and fewer drug interactions, in the event of severe bleeding, there is no known antidote for Xarelto, unlike warfarin, which is easily reversed with a dose of vitamin K. Gastrointestinal bleeding carries with it a substantial risk of serious injury and even death. Those at risk for uncontrollable bleeding events should consider the risks and benefits of using Xarelto.

Xarelto Lawsuits Charge Failure to Warn

Severe bleeding events have precipitated numerous lawsuits against Janssen Pharmaceuticals Inc. and Bayer Corp., the manufacturers of Xarelto, alleging the manufacturers put patient lives at risk by failing to provide product labeling that sufficiently warned consumers about the possibility of uncontrollable hemorrhaging caused by Xarelto use.

There are currently more than 300 Xarelto lawsuits in federal litigation in Louisiana, and another 160 pending in a mass tort proceeding in Pennsylvania. The plaintiffs in these lawsuits allege that they never would have used Xarelto had they known of the risks, and also that Janssen and Bayer misled health care providers by claiming that follow-up testing is unnecessary with the medication.