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​Drug company facing US lawsuits over Xarelto bleeding events

Patients allegedly suffer adverse reactions and even death after use of anticoagulant drug.

Posted on 18 September 2014

Lawyers in the United States have brought proceedings against Bayer, manufacturers of Xarelto, after their clients allegedly suffered uncontrollable bleeds and even death following their use of the anticoagulant drug. Lawyers argue that Bayer failed to warn patients of the very serious risks of taking the drug and their clients would not have taken Xarelto if they had been properly warned.

Xarelto is a new generation blood thinning drug manufactured by the German pharmaceutical giant Bayer. It was approved for use in Europe in 2008 and in the United States in 2011.

Patients undergoing hip or knee replacement surgery and patients with atrial fibrillation, DVT or pulmonary embolism are at a risk of blood clots forming and moving to another part of the body. The active substance in Xarelto, rivaroxaban, reduces the risk of blood clots forming in the veins and arteries.

Recently, concerns have been raised regarding the safety of Xarelto. Similar blood thinners, like warfarin, carry the risk of internal bleeding including brain haemorrhage. However, it has been reported that if a patient suffers internal bleeding on Xarelto, then it cannot be easily controlled or reversed making the drug potentially more dangerous than other treatments on the market.

Xarelto is marketed as being easier to use than warfarin, which requires blood monitoring during treatment.

Product liability lawyer, Brian McFerran, commented:

“Patients have a reasonable expectation that if they are prescribed a relatively new drug by their doctor, then that drug is at least as, if not more, effective and safe than the leading drug on the market at the time. 

"It is a matter of concern to hear it alleged that patients may not have been warned that they are at risk of uncontrollable bleeding, especially considering that the evidence is suggestive that Xarelto is no more effective than warfarin.”

The product liability team at Leigh Day specialise in bringing claims against manufacturers of drugs and medical devices.