Xarelto Bleeding Complications: Convenience Can be Deadly

Washington, DCThe world revolves around convenience. And so it is that the long-used blood thinner warfarin, widely held as relatively safe though a bit of a pain in the neck to monitor, has taken a back seat to new blood thinning drugs like Xarelto that require less stringent monitoring and fewer blood tests. The downside is the risk for a Xarelto bleeding issue, for which there is no way to stop it.

The legal community is anticipating a spike in the Xarelto lawsuit portfolio based on a number of factors, not the least of which is a notation by the Institute for Safe Medicines, last May, regarding the number of serious Xarelto bleeding complications having overtaken those of Pradaxa - the first new-age anticoagulant to be approved - by early 2013.

And it’s not just in the US that Xarelto bleedout is a problem. In Ireland, the Healthcare Products Regulatory Authority (HPRA, formerly the Irish Medicines Board), noted 175 reports of suspected adverse events involving the use of Xarelto, with 14 deaths. Of interest is the fact that the number of Xarelto bleeding complications was more than twice the number of similar adverse reactions involving Pradaxa.

Boehringer Ingelheim’s Pradaxa may have been first out of the gate, but Xarelto appears to be rapidly becoming a greater source of concern. And with little wonder, given the lack of an immediate antidote to stem a Xarelto bleeding issue were one to arise.

Warfarin, the traditional blood thinner, also poses a threat for uncontrollable bleeding. However, that threat is minimized with regular blood tests and monitoring, which is a necessity with warfarin use. Xarelto is described as not requiring such stringent monitoring and, therefore, is much more convenient to use.

However, the greatest difference between warfarin (Coumadin) and rivaroxaban (Xarelto) is the capacity for a doctor or surgeon to immediately stem a warfarin bleeding event by employing an antidote that almost immediately reverses the blood thinning properties of warfarin in the bloodstream.

Once a Xarelto bleeding event starts, it could be game over…

With Xarelto, there is no similar capacity to stem a hemorrhaging event. Such a lack of an antidote can lead and has led to fatalities.

The Sunday Business Post (7/27/14) reports that a number of surgeons in Ireland have stopped using Xarelto and Pradaxa during surgery, due to an “excessive number” of bleeding complications during surgical procedures.

There are reports that manufacturers of these latest-generation blood thinners are researching possible antidotes that could be employed to stem a hemorrhage such as a Xarelto bleedout, but have so far come up empty-handed. Therefore any patient currently taking Xarelto risks the potential for a Xarelto bleeding issue that cannot be stopped once in starts.

With warfarin, hemorrhage is also possible. But with warfarin, there is a way to stop it. With regard to Xarelto and Pradaxa, there is no way to stem the tide.

Pharmaceutical giants Bayer and Johnson & Johnson (J&J), which had partnered to manufacture and market Xarelto, are satisfied that warnings on product labeling with regard to Xarelto bleeding complications and other Xarelto side effects are sufficient. And rather than pull back on Xarelto, in view of the missing reversing agent, Xarelto’s principals are looking to expand the various indications and uses for rivaroxaban. According to Legal Monitor Worldwide (8/30/14), Bayer and J&J would like to see Xarelto indicated for treatment of a dozen or so conditions, further widening the market for Xarelto, rather than shrinking it.

Given the similarity of Xarelto and Boehringer Ingelheim’s Pradaxa, attorneys are gearing up for an expected tidal wave of litigation filed by disgruntled patients, or their families and estates. Last May it was reported that Boehringer Ingelheim agreed to a $650 million settlement to take care of about 4,000 lawsuits with regard to bleeding issues involving Pradaxa.

Lawyers think Xarelto will be facing a similar fate, and their ad dollars tell the tale. According to The Silverstein Group Mass Tort Ad Watch, legal firms spent $1.2 million in July of this year targeting the Xarelto file. That’s up from just $8,000 a month earlier.

With aging baby boomers, and a constant bent toward added convenience fueling a mass exodus away from warfarin toward new-generation blood thinners like Xarelto, this could be the tip of a formidable iceberg. A professor and consulting endocrinologist from Dublin put it politely when he said that the new clotting drugs such as Xarelto were “causing problems.” The debate, said Professor Donal O’Shea in the Sunday Business Post, would be “healthy.”