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Bayer Facing Lawsuits over Xarelto Bleeding Events

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Los Angeles, CA: Bayer AG and Janssen, the makers of Xarelto (Rivaroxaban) EI, are facing a wrongful death lawsuit recently filed by the family of a man who suffered irreversible brain bleeding allegedly as a side effect of taking the blood thinner: he died shortly thereafter.

Xarelto is a new generation anticoagulant that is being linked to an increasing number of similar bleeding events, which, in some cases, have allegedly resulted in severe and often fatal injuries from uncontrolled hemorrhaging.

According to this latest lawsuit, the deceased man was prescribed Xarelto in July 2012 for treatment of atrial fibrulation, however, after using the medication for less than 10 days he suffered a fatal bleeding event and passed away on August 1, 2012.

Xarelto is part of a class of drugs known as direct thrombin inhibitors, which are used to reduce the risk of blood clots and strokes. The medication was jointly developed by Bayer and Janssen, and became available in 2011.

Xarelto is marketed as being easier to use than warfarin, which requires blood monitoring during treatment. However, Bayer and Janssen allegedly withheld the fact that currently there is no antidote for the agent, unlike warfarin, where doctors can quickly reverse the blood thinning effects of the medication if hemorrhaging occurs.

According to this latest lawsuit, "As part of their marketing of Xarelto, Defendants widely disseminated direct-to-consumer advertising campaigns that were designed to influence patients, including Decedent, to make inquiries to their prescribing physician about Xarelto and/or request prescriptions for Xarelto,"the complaint filed by McGowen states. "In the course of these direct-to-consumer advertisements, Defendants overstated the efficacy of Xarelto with respect to preventing stroke and systematic embolism, failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Xarelto, and that such irreversibility could have permanently disabling, life-threatening and fatal consequences."

The FDA cited Bayer and Janssen on June 6, 2013, for putting out promotional material for Xarelto that was false or misleading because it minimized the risks associated with the drug.

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