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Probe: Xarelto among anticoagulants suspected in disproportionate death

Newer anticoagulant drugs are not prescribed nearly as often as the age-old blood thinner warfarin; nevertheless, Xarelto and similar drugs are linked to disproportionate death from the risk of unstoppable bleeding. This is one of the findings of an investigation that the Milwaukee Journal Sentinel and MedPage Today conducted.

The reporters reviewed medication adverse event reports that health care professionals and the pharmaceutical corporations submitted to the U.S. Food and Drug Administration for a part of the research. They also examined published medical scientific findings.

Since 2010, according to the investigation, the newer anticoagulants Pradaxa, Xarelto and Eliquis have been linked to at least 8,000 deaths, but warfarin has been suspect in 700 during that period. Oddly, warfarin was prescribed three times more often.

Injury and death generate litigation. Pending Xarelto lawsuits outnumber those associated with the other two new anticoagulants. As of Aug. 17, more than 1,200 federal Xarelto lawsuits were pending before the U.S. District Court for the Eastern District of Louisiana, where pretrial proceedings have been economically coordinated before a single judge. And those are only the federal cases that have been transferred there. Many more cases exist in state courts.

Janssen Pharmaceuticals is among the defendants.

In late 2014, the panel of federal judges who grouped those federal actions in Louisiana wrote, "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. Issues concerning the development, manufacture, regulatory approval, labeling, and marketing of Xarelto thus are common to all actions."

The journalists cited medical journal articles summarizing medical scientific findings. One of the articles, which the medical journal Case Reports in Hematology released in November 2014, centered on a case study out of Detroit where a 39-year-old woman taking rivaroxaban, or generic Xarelto, presented physicians with a two-week history of vaginal bleeding. She had been switched from warfarin to Xarelto six weeks prior to her hospital visit.

As Xarelto is one of a new generation of blood thinners on the market, physicians who dealt with the Detroit patient established from the outset of their article, "There is no agent for immediate reversal of the new oral anticoagulants in the status quo and the management of such cases can be difficult, as exhibited with our patient."

The victim's circumstances were not pretty.

Through the next day, despite a transfusion and attempts to stop the bleeding with 2.5 mg of intravenous conjugated estrogen, which gynecologists recommended, the patient continued to bleed. She needed another four units of packed red blood cells by the third day.

Gynecologists tried to stop the bleeding by deploying a balloon tamponade, which is an inflated device that compresses vessels to stop bleeding. That attempt failed.

A procedure known as endometrial ablation stopped the bleeding on the next day.

The doctors summarized, "... bleeding with warfarin is managed with a clear protocol for emergent reversal ... Recent trials using current reversal modalities for rivaroxaban have not yielded promising results."

Many Xarelto bleeding patients have not been as fortunate as the Detroit patient. She survived! This is the reason that patients who experienced bleeding injury after using Xarelto - as well as the surviving family members of apparent Xarelto decedents - should contact an attorney to find out whether they are entitled to compensation. An attorney experienced in pharmaceutical injury litigation can be a prudent option.

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