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Potential Xarelto antidote good news but late for some

There is encouraging news, albeit tardy to some of us, in regard to minimizing the risk of uncontrollable bleeding linked to the use of the blood thinner Xarelto (rivaroxaban). As hundreds of Xarelto lawsuits are pending in U.S. courts, a pharmaceutical company believes it is close to developing an antidote which may ameliorate the severe bleeding risk.

Portola Pharmaceuticals announced March 2 that in the first phase of testing a test drug known as andexanet alfa "administered as an intravenous bolus produced rapid and significant reversal of the anticoagulant effect of Xarelto."

The corporation's executive vice president, Dr. John T. Curnutte, said in the announcement that "we believe that andexanet alfa has the potential to become the first approved universal antidote for Factor Xa inhibitors and the standard of care to manage bleeding associated with these novel anticoagulants."

Consistent with U.S. regulatory form, the corporation plans to brief the U.S. Food and Drug Administration about its findings. As Curnutte explained, "We plan to submit these data as part of our Biologics License Application to the FDA by the end of this year."

This nugget of research could portend a bonanza of benefits to public safety. And that would be an ideal outcome indeed. Nevertheless, there remains another side of this coin.

Xarelto Vessel Bleed.jpg

The undertow of this seeming breakthrough is that Xarelto lacked a reversal agent during its marketing and manufacture, and people suffered severe inevitable bleeding injury. Some Xarelto patients died. Unfortunately, neither the victims nor their health care professionals were properly warned about the alleged unreasonable bleeding risk.

The FDA in January 2014 approved a Xarelto labeling change that included the language, "A specific antidote for rivaroxaban is not available."

Xarelto lawsuits are being handled in state and federal courts. The Xarelto attorneys at Reich & Binstock, who operate in all 50 states, are investigating whether their clients are entitled to compensation for medical expenses and other losses. If they have a viable case, Reich & Binstock will fight hard for justice on their behalf.

Meanwhile, there has been an interesting development concerning federal litigation.

At the federal level, as of March 16, there were 311 pending Xarelto lawsuits centralized for uniform pretrial management at the U.S. District Court for the Eastern District of Louisiana. The U.S. Judicial Panel on Multidistrict Litigation is the body responsible for grouping those cases before a single judge in December 2014.

In the ruling that transferred those federal cases to Eastern Louisiana, the panel held, "These actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding or other injuries as a result of taking Xarelto (rivaroxaban) and that defendants did not adequately warn prescribing physicians or consumers of the risks associated with Xarelto, including the potential for severe or fatal bleeding and the unavailability of a reversal agent to counteract Xarelto's anticoagulation effects."

The main defendants are Johnson & Johnson and one of its subsidiaries.

Any Xarelto patient who has experienced any of the following conditions may be entitled to compensation:

1. Internal bleeding (rectal and intestinal)

2. Brain hemorrhage

3. Blood clots

4. Embolism

At Reich & Binstock, the consultation is free. It will not cost Xarelto victims anything to get an experienced product liability attorney at Reich & Binstock to analyze the circumstances and to explain all of the legal options. That also goes for the family members of those who died after suffering from apparent Xarelto complications.

The law firm may be reached either by calling the toll-free number, 1-866-LAW-2400, or by submitting an electronic message through this web page.

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