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18 May 2015

Uncontrolled Bleeding Events Underscore Xarelto Risks

Xarelto is a blood thinner medication — a member of the new oral anti-coagulant (NOAC) drug class — which is rapidly earning a reputation for its risks, primarily uncontrolled bleeding incidents which have led to a slew of near-deaths and fatal bleeding incidents.

What is Xarelto?

Manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals, in conjunction with Bayer, Xarelto was approved by the FDA and released in 2011.

Used to prevent stroke and blood clots, Xarelto is prescribed for individuals who are suffering from or prone to an array of different conditions, such as atrial fibrillation, pulmonary embolism and deep-vein thrombosis, among others.

Along with a similar NOAC drug, Pradaxa, Xarelto originally made headlines for being among the first real alternatives to the most widely used blood thinner, Coumadin/warfarin. Coumadin made many physicians and patients nervous as it requires frequent monitoring to ensure the warfarin remains at therapeutic levels.

But Xarelto had a major downside: a downside that many patients and even physicians say they weren’t sufficiently cautioned about: there is no antidote to Xarelto.

All blood thinner medications leave the patient prone to uncontrolled bleeding incidents, as the drugs thin the blood, making it more difficult for clots to form. Clotting is required to stop bleeding, whether it’s a bruise, a cut or an internal injury. But Coumadin does have an effective antidote, so in the event of a bleeding incident, the drug’s impact can be reversed and the bleeding can be brought under control using vitamin K.

Xarelto lacks an antidote, which means that once the bleeding starts, there’s no treatment. The patient must receive blood transfusions and other supportive care until the drug leaves their system to the point where clotting can resume. It’s an approach that’s woefully insufficient in cases of serious bleeds, resulting in lengthy hospitalizations and multiple fatalities.

Xarelto patients are at risk from a broad range of different incidents, including some very minor injuries. High-risk events for a patient on Xarelto include:

Xarelto Lawsuits

According to one medical trial, in a single year, there would be 3.6 major bleeding incidents for every 100 individuals on Xarelto – a relatively high rate. As of December 2014, the Institute for Safe Medication Practices had reported at least 151 deaths and 2,081 serious bleeding incidents involving Xarelto.

Yet many patients have filed suit against Xarelto manufacturers, claiming that marketing materials did not emphasize this high risk of uncontrolled bleeding incidents. Dozens of Xarelto lawsuits have been filed by those who suffered major bleeds after taking Xarelto. A number of individuals who lost family members to bleeding incidents while they were on Xarelto have also filed suit, including Ruth E. McGowan.

According to a suit filed in US District Court for the District of Vermont, McGowan’s father, Thomas C. Dunkley, passed away in August 2012. After just 10 days on the drug, he suffered an uncontrolled bleed that proved fatal. He had been taking Xarelto to reduce the risk of health issues stemming from conditions like deep-vein thrombosis, and atrial fibrillation-related pulmonary embolism.

In addition to claims that patients and physicians were never properly warned of the severe risk of uncontrolled and potentially fatal bleeds, Xarelto users have also brought into question why the drug was ever recommended over Coumadin in the first place.

While Coumadin does require more intensive patient monitoring to ensure therapeutic levels of the drug, critics argue that Xarelto’s potential for uncontrolled bleeding, combined with the lack of an antidote represent, represents a much higher risk. Some critics have even gone so far as to claim that it was negligent and irresponsible for Bayer/Janssen Pharmaceuticals to release a dangerous drug that lacked an antidote.

There’s also the expense. Coumadin costs around $400 per year. Xarelto costs about $3,000 annually. It’s a point that many have highlighted as being extremely suspect, especially when one considers this fact in combination with the fact that the drug lacks an antidote.

Notably, there have been reports that a Xarelto antidote/reversal agent is in development. But with clinical trials and FDA approvals often taking years, it could be quite a while before an antidote is available. Until then, Xarelto users will be at high risk of suffering fatal or near-fatal uncontrolled bleeding events.

To compound matters, some patients have reported suffering blood clots while taking Xarelto — a risk that’s supposed to be eliminated by the anticoagulant drug.

If you’ve suffered complications while taking Xarelto or lost a family member as the result of an uncontrolled bleeding event, you may be eligible to receive compensation for medical bills, lost wages, pain and suffering and other losses. The compassionate team at the Meldofsky Law Firm LLC is here to provide the resources you need to seek out the compensation you deserve. Our xarelto legal team is here to provide a confidential consultation regarding your case.

You may be eligible for financial compensation.

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