With Xarelto Bleeding Events, There’s No Turning Back

August 11, 2014, 8:00AM. By Gordon Gibb

Burlington, VTA member of the New Oral Anticoagulant (NOAC) class of drugs heralded as the natural successor to the decades-old warfarin as a blood thinner for stroke and blood clot prevention appears to be gaining a reputation as a high-risk drug. Like Pradaxa, Xarelto has been embraced by the medical community due to the need for less frequent monitoring than that of Coumadin (warfarin). And yet Xarelto is much more expensive and, unlike its graybeard warfarin counterpart, does not benefit from a reversal agent in the event of uncontrolled Xarelto Bleeding Events.

When this happens, a patient can easily die from uncontrolled bleeding from a relatively minor injury. A nosebleed, perhaps. Even a bruise.

Plaintiffs filing a Xarelto lawsuit claim the manufacturers of the new-age anticoagulant withheld important data from clinical trials related to Xarelto irreversible brain bleeding and other bleeding side effects.

That trial, dubbed ROCKET, revealed the potential for 3.6 major bleeds per 100 person years - a number that is considered high. And yet, according to many a Xarelto lawsuit, the manufacturing and marketing partnership of Johnson & Johnson and Bayer have not adequately shared this information with patients and health care professionals.

One recent Xarelto lawsuit was filed last month in the US District Court for the District of Vermont. Plaintiff Ruth E. McGowan, the daughter of Thomas C. Dunkley, filed the lawsuit on behalf of her late father, who died August 1, 2012. According to court records, Dunkley was prescribed Xarelto in order to reduce the risk of deep vein thrombosis and pulmonary embolism from atrial fibrillation.

Following use of Xarelto for a period of 10 days, Dunkley experienced Xarelto uncontrollable hemorrhaging, and died.

With Xarelto, there’s no turning back

Plaintiffs claim that not only was the potential for Xarelto side effects withheld, the wisdom inherent with using Xarelto over the much older Coumadin is somewhat suspect. First, there’s the cost - $3,000 a year for Xarelto v. about $400 for Coumadin.

And while there is less monitoring needed for Xarelto, critics claim that such a benefit does not mitigate the costs in terms of both price and the potential for a fatal bleeding event.

It should be noted that bleeding events are also possible with Coumadin. In fact, stringent monitoring is needed due to the variability of warfarin and the impact things like everyday foods can have on the levels of warfarin in the bloodstream and thus, the active anticoagulant.

However, what critics point to with increasing frequency is the lack of a reversal agent in the event of Xarelto uncontrollable hemorrhaging. With Coumadin there is a way to reverse the effects of the drug - and the impact it has on a sudden bleeding event - through the use of vitamin K. The latter has been found to sufficiently counteract the anticoagulant properties of warfarin, allowing the blood to clot as it normally is able to do, stopping the bleeding and in most cases saving the life of the patient.

With Xarelto, there is no such reversing agent available. It has been reported that a reversing agent is in development, but is not yet ready.

Hence, when patients begin suffering Xarelto bleeding events, there is absolutely no medical way to stop them.

The Institute for Safe Medication Practices (ISMP) has reported that no fewer than 2,081 reports of serious Xarelto complications have been filed, together with at least 151 deaths.

Coumadin may be an old and tired anticoagulant. However, given the availability of means to reverse Coumadin’s propensity to thin the blood - and given the lower cost - critics suggest anticoagulants like Xarelto not only lack increased benefit over warfarin, they could put the life of a patient in serious jeopardy, without need.

All due to the need for less monitoring on the part of health care professionals.

Most Xarelto lawsuit plaintiffs would rather accept the frustration of monthly or even weekly monitoring required by warfarin use, than the potential for a serious bleeding event or even death from something as innocuous as a bruise or a nosebleed.

The Xarelto lawsuit is Ruth E. McGowan et al v. Janssen Research & Development LLC et al, Case No. 2:14-cv-00159-cr, filed July 25, 2014 in US District Court in the District of Vermont.