Study Finds Higher Rates of Brain Bleeding with Xarelto than Pradaxa

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JAMA Study Compares Stroke, Bleeding, and Mortality in Xarelto vs. Pradaxa

Xarelto (rivaroxaban) and Pradaxa (dabigatran) are both new-generation anticoagulants used to reduce the risk of blood clots, stroke and death in patients with atrial fibrillation. In the several years since the drugs have been on the market, there have been questions related to the medications’ bleeding risks. Lawsuits have been filed over both Pradaxa and Xarelto alleging that the manufacturers failed to adequately disclose bleeding risks.

Parker Waichman LLP is a national personal injury law firm that represents numerous clients in drug injury lawsuits. The firm continues to offer free legal consultations to anyone with questions about filing a Xarelto lawsuit.

In November 2016, JAMA Internal Medicine published a study titled “Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation”. Researchers looked at data from 118,891 patients. The study found that Xarelto, known by its generic name as rivaroxaban, “was associated with significantly increased intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding, and nonsignificantly reduced risk of thromboembolic stroke and increased risk of mortality. The absolute increase in intracranial hemorrhage with rivaroxaban treatment exceeded its reduced rate of thromboembolic stroke.”

Overall, the study found higher rates of intracranial and major extracranial bleeding with Xarelto compared to Pradaxa.

Bayer, J&J Face Xarelto Bleeding Lawsuits

Parker Waichman notes that Bayer and Johnson & Johnson’s Janssen unit are facing thousands of lawsuits alleging that Xarelto caused bleeding injuries, including brain bleeding and gastrointestinal bleeding. The drug makers are accused of failing to disclose the risk of uncontrollable bleeding with Xarelto. Some lawsuits are wrongful death claims, filed on behalf of people who died after taking the anticoagulant.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated Xarelto bleeding lawsuits into a federal multidistrict litigation (MDL). An MDL is a type of mass tort where similar lawsuits are grouped together in one court before one judge. Transferring cases in this manner helps make complex litigation more efficient because it eliminates the need for duplicate discovery and streamlines the legal process. Lawsuits in an MDL share common factual allegations.

In the Xarelto MDL, plaintiffs allege that Xarelto caused bleeding injuries and that Bayer and J&J failed to warn patients and the medical community about the risks. Plaintiffs also allege that the companies marketed Xarelto as superior to other anticoagulants while failing to disclose the dangers.

According to court records, the Xarelto MDL contains 16,285 lawsuits. Cases are consolidated in the U.S. District Court for the Eastern District of Louisiana. The MDL was created in December 2014.

One Xarelto wrongful death claim was filed by a Wisconsin man whose wife died. The lawsuit alleges that Xarelto is defective, causing her to suffer fatal bleeding. The suit alleges that Bayer and Janssen are liable for “negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, advertising, distribution, labeling, and/or sale of the pharmaceutical drug Xarelto.”

Xarelto Background

Xarelto, Pradaxa and Eliquis are all part of a new generation of blood thinners marketed to compete with warfarin (sold under the brand name Coumadin). Pradaxa was the first to gain approval in 2010. Xarelto was introduced the following year. Lawsuits have been filed over Pradaxa, Xarelto and Eliquis.

Anticoagulants are prescribed to prevent blood clots, stroke and heart attack in patients with deep vein thrombosis and in patients undergoing a knee or hip replacement surgery. Deep vein thrombosis is when a blood clot forms in one of the deep veins, usually the legs. If a piece of the clot breaks off, it can get stuck in the lungs and cause a life-threatening condition known as pulmonary embolism. These conditions frequently occur together, and are collectively referred to as venous thromboembolism.

Warfarin has been on the market for decades to reduce the risk of blood clots in patients with atrial fibrillation, an abnormal heart rhythm that increases the risk of thrombotic events. Patients taking warfarin face certain limitations, including dietary restrictions and the need to undergo regular blood testing.

The newer anticoagulants do not have these requirements. However, lawsuits point out that they have one drawback; there is no antidote, or reversal agent, to counteract the drug’s effects if the patient has hemorrhaging. This effectively means that bleeding can become uncontrollable in Xarelto and Eliquis users, lawsuits state. Pradaxa formerly did not have an antidote, but a reversal agent was approved in 2015. Bleeding in warfarin patients can be reversed with vitamin K.

In 2014, Boehringer Ingelheim settled Pradaxa lawsuits on the eve of trial for $650 million.

Lawsuits allege that drug makers failed to adequately warn about the lack of an antidote with Xarelto. Plaintiffs allege that if the companies had fully disclosed the risks, they would not have agreed to take the anticoagulant.

In 2014, the Xarelto label was updated to warn about the lack of an antidote. “Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement,” the revised label states.

Xarelto plaintiffs also question the integrity of clinical data in the ROCKET AF study, which was used to approve Xarelto. Plaintiffs claim that the data did not accurately compare the risks of warfarin to Xarelto. During the trials, a now-recalled device was used to measure how fast a patient’s blood is clotting.

The device, the Alere INRatio and INRatio2, were recalled in 2014 and withdrawn in 2016. The recall was initiated because the device may give inaccurately low readings. “The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) may provide an INR result that is lower than expected result obtained using a laboratory INR method,” according to the recall alert. “Incorrect results can also occur if a patient has certain medical conditions.

These conditions include, anemia, conditions associated with elevated fibrinogen levels, or unusual bleeding or bruising. Incorrect results can also occur if the instructions in the labeling for performing the test are not followed.” Questions have been raised about whether the recalled devices could have inadvertently skewed data to favor Xarelto over warfarin.

The FDA labeled the recall as Class I, the most serious recall status. A Class I recall indicates that exposure to the recalled device presents a reasonable risk of serious injury or death.

Filing a Xarelto Lawsuit

If you or someone you know suffered uncontrollable bleeding related to the use of Xarelto, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).