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New studies released on Xarelto bleeding

Medical science and countless victims have known all about the risks of gastrointestinal bleeding associated with the anticoagulant Xarelto (rivaroxaban). The bleeding risk is at the center of Xarelto lawsuits that are being filed across the nation by bleeding victims or by their surviving next-of-kin who have sought legal counsel and who have decided not to suffer in silence. Nevertheless, a pair of studies published in 2015 focus - if you will - on eye bleeding.

The medical journal JAMA Ophthalmology on June 25 released a study that California-based vision medicine researchers conducted. In this study, three elderly men took a pair of blood thinners, warfarin and rivaroxaban, the latter the generic for Xarelto. The patients were being treated for a type of abnormal heart rhythm called non-valvular atrial fibrillation. After they stopped taking warfarin and stayed on generic Xarelto, the patients, as researchers wrote, "...developed spontaneous vitreous hemorrhage after initiating rivaroxaban anticoagulation."

Vitreous hemorrhage is a condition in which blood collects in the clear gel that fills a portion of the inside of the eye.

The authors of the study concluded, "Rivaroxaban is increasingly prescribed as a replacement for warfarin sodium in the management of atrial fibrillation. Rivaroxaban anticoagulation may be associated with spontaneous vitreous hemorrhage. The risk of hemorrhage may be particularly elevated during the transition period when patients are switched from baseline anticoagulant to rivaroxaban therapy and are taking both anticoagulants simultaneously."

The journal Retinal Cases and Brief Reports released July 13 a piece that University of Kansas School of Medicine researchers wrote concerning eye bleeding and Xarelto. This study was a case report of a 63-year-old man who suffered "subretinal hemorrhage" after using generic Xarelto. To be precise, authors explained the phenomenon as "recurrent subretinal hemorrhage associated with rivaroxaban use."

Xarelto bleeding is only half the story. As victims and their loved ones attest, Xarelto bleeding can be uncontrollable because there is no agent available to stop the bleeding.

Although Xarelto lawsuits are being filed nationwide, many cases are before a state trial court in Philadelphia, where a mass tort program was created in January, and before a federal district court in Louisiana.

The U.S. Judicial Panel on Multidistrict Litigation centralized federal Xarelto lawsuits for pretrial management before a single judge at U.S. District Court for the Eastern District of Louisiana. The case load is growing exponentially as alleged victims seek legal counsel and attempt to hold the manufacturer, Janssen Pharmaceuticals, accountable for their injuries.

As of Jan. 25, there were 86 Xarelto lawsuits centralized before the Louisiana federal court. As of July 15, that number stood at 805 pending actions.

"These actions," the panel wrote in 2014, "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."

People injured by the drug often allege that the manufacturer knew about the Xarelto bleeding risk but did not properly warn about the risk of bleeding that can be so serious that transfusion may be required. A 2011 clinical review of the so-called RECORD study delved into that risk. The piece was submitted to the U.S. Food and Drug Administration, which originally approved Xarelto in 2011. The review uses "rivaroxaban" instead of the drug's brand name as it compares its performance to that of a similar drug known generically as enoxaparin.

"The major risk of rivaroxaban treatment is bleeding complication," the 2011 clinical review reads. "In RECORD studies, the incidence of major bleeding was higher with rivaroxaban treatment than with enoxaparin. One fatal bleeding event (gastrointestinal bleeding) was reported after rivaroxaban treatment as compared to none with enoxaparin. Two patients experienced critical organ bleeding events after rivaroxaban treatment (retinal hemorrhage and adrenal hemorrhage) as compared to five patients in the enoxaparin group (catheter-site hemorrhage, subdural hemorrhage, extradural hematoma, catheter-related complication, and spinal epidural hemorrhage)..."

The FDA approved Xarelto for the following purposes:

  • To reduce the risk of deep vein thrombosis, or DVT, and pulmonary embolism, or PE, that might occur following knee replacement or hip replacement surgery
  • To actually treat DVT and PE and to reduce their recurrence following initial treatment
  • To reduce the risk of stroke in people who have non-valvular atrial fibrillation

Anyone who has suffered from severe bleeding after using Xarelto should contact an attorney to determine what legal options exist. There may be an entitlement to compensation for medical expenses and for other losses.

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