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Xarelto Blood Thinner Led to Severe Bleeding, Lawsuit Alleges

Filed February 21st, 2014 Cynthia Diaz-Shephard

A lawsuit was just filed against Johnson & Johnson and Bayer AG by a woman who alleges having suffered severe internal bleeding after treatment with Xarelto, a blood thinner.

The lawsuit is believed to be the first tort suit filed in the Philadelphia Court of Common Pleas over Xarelto, according to Law360. Among the complaints, the lawsuit indicates that Xarelto should not be sold due to allegedly high bleeding risks; the lawsuit alleges that Johnson & Johnson and Bayer were negligent in how they introduced Xarelto. Of note, the lawsuit comes after a Pennsylvania Supreme Court decision this January that found pharmaceutical companies may be held responsible for marketing drugs that are found to be too dangerous for use.

The lawsuit also indicates that the woman was hospitalized in February 2013 for severe internal and gastrointestinal bleeding following use of Xarelto. According to the lawsuit, she states that, “As the manufacturers and distributors of Xarelto, defendants knew or should have known that Xarelto use was associated with irreversible bleeds,” according to Law360. The woman also argues that Xarelto should never have been sold and that Xarelto’s warning label does not sufficiently advise customers about its risks.

The lawsuit compares Xarelto to competitor drug, Pradaxa, which is manufactured by Boehringer Ingelheim International GmbH. More than 2,000 Pradaxa bleeding lawsuits allege serious injuries and were organized into a multidistrict litigation (MDL), according to Law360.

Xarelto received U.S. Food and Drug Administration (FDA) approval in July 2011 to reduce risks for blood clots, deep vein thrombosis (DVT), and pulmonary embolism following knee or hip replacement surgery. The recommendation was broadened In November 2011 to include treatment of abnormal heart rhythm, which leads to strokes. Approval for that use went against agency staff recommendations; staff raised safety concerns, according to Law360. Last week, for the third time, the FDA denied expansion of Xarelto for use in the treatment of acute coronary syndrome (ACS).

Xarelto is a key Bayer product, according to a prior Reuters report, and is one of a newer class of blood thinners tied to increased bleeding risks. In fact, many experts believe the drug’s risks may negate any benefits in patients diagnosed with ACS. Xarelto is an Xa inhibitor, which is a type oral anti-coagulant that may potentially increase risks in ACS patients for serious bleeding events by as much as three-fold. Xarelto and similar drugs were believed to offer an alternative to the long-used warfarin in the prevention of blood clots and strokes in patients diagnosed with atrial fibrillation (AF).

A prior study revealed that, although a significant reduction in ischemic events was seen in research involving patients taking new generation anti-coagulant therapies, when compared to the placebo group, a three-fold increased risk for a major bleeding event was seen in those patients taking factor Xa inhibitors, such as Xarelto, or a direct thrombin inhibitor, following ACS diagnosis. The researchers concluded that the bleeding risk almost fully negated the drugs’ benefits.

While warfarin—known by the brand, Coumadin—may lead to internal bleeding, antidotes are available for warfarin bleeding reactions. Warfarin calls for regular blood monitoring or frequent doctor follow-up. As with any blood thinner, Xarelto may lead to serious internal bleeding events; however, where a warfarin bleed may be stopped with the proper treatment, there is no known antidote for Xarelto bleeding.

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