Eye Hemorrhaging and Stomach Bleeds Tied to Xarelto

Two recent studies have linked Xarelto, a blood-thinning drug manufactured by Johnson & Johnson, to an increased risk of stomach bleeds and eye hemorrhaging. In the first study, two doctors found a significant number of patients in their 70’s and 80’s who switched from Warfarin to Xarelto suffered a bleed between the lens of the eye and the retina. These cases were reported in the June 2015 issue of JAMA Ophthalmology. The second study, published in April 2015 in the British Medical Journal, concluded a twofold higher risk of stomach bleeding with Xarelto as compared to Warfarin could not be ruled out.

Xarelto Linked to Uncontrolled Bleeding Events in the Past

Xarelto has been linked to uncontrolled bleeding among those taking the drug in the past. While these new side effects are serious, the primary concern remains an uncontrolled bleed which could lead to death. Pradaxa, a blood thinner which works in a similar manner as Xarelto, recently settled more than 4,000 claims involving uncontrolled bleeds for approximately $160,000 per case. Xarelto currently has more than 300 lawsuits pending in federal litigation in Louisiana, and another 160 cases pending in Pennsylvania’s mass tort proceeding.

Warfarin vs. Xarelto

A number of fatal and near-fatal bleeding incidents have occurred among patients taking Xarelto. Coumadin and Warfarin, an older class of blood thinners, have been prescribed for more than six decades, however patients taking the drugs must be monitored regularly. Both drugs have certain food and drug interactions, and the dosage is dependent on the patient’s age, gender and weight. Xarelto, and similar drugs such as Pradaxa, are prescribed in a standardized dosage, there is no blood monitoring required, and there are no known food or drug interactions.

How is Xarelto Used?

Xarelto (Rivaroxaban) reduces the ability of the blood to clot, reducing the risk of dangerous or fatal blood clots forming in the blood vessels. Xarelto was first approved to use for patients undergoing hip or knee replacement surgery in order to prevent blood clots or treat blood clots in patients with a history of deep vein thrombosis or pulmonary embolism. Xarelto is also prescribed for patients with atrial fibrillation. While it may sound like Johnson & Johnson created a near-magical blood-thinning drug, there are, unfortunately, some negative issues associated with the drug.

The Downside of Xarelto

When a patient taking Warfarin or Coumadin experiences an uncontrolled bleed, the doctor can administer a shot of Vitamin K, which fairly quickly reverses the effects of the drug. There is no such reversing agent for Xarelto; when a patient is bleeding uncontrollably, doctors have no options other than transfusing blood to the patient, hoping the bleeding will stop on its own. This is particularly concerning among the elderly who take Xarelto. Older patients, particularly when they live alone, could have a dizzy spell, take a fall in their home, receive a relatively minor wound, and bleed out before being found by anyone.

Deaths Associated With Xarelto

In 2012, fifty-eight deaths were tied to the use of Xarelto, and in 2013, another seventy-two. While Xarelto currently contains two black box warnings, neither is related to uncontrolled bleeding events. Patients taking Xarelto have suffered rectal bleeding and brain hemorrhage, and this latest research adds the risk of gastrointestinal bleeding and hemorrhaging from the eyes. Despite three FDA rejections for the expanded uses of Xarelto, Johnson & Johnson and its subsidiaries, Bayer and Janssen, continue to push for additional approval, particularly to treat acute coronary syndrome and clogging of heart stents.

While a number of studies—including these latest studies regarding stomach bleeds and eye hemorrhaging—implicate Xarelto in potentially fatal bleeding events, Johnson & Johnson continues to aggressively push the drug. Although Xarelto has been on the market only since late 2011, sales of the drug topped $1 billion by the last quarter of 2014. Even so, this new data comes at a tough time of J & J as they fight an ever-increasing number of claims. It is expected the Xarelto litigation will be lengthy and that more plaintiffs will come forward as time passes.

National Dangerous Drug Lawyers

If you have suffered medical complications, pain, or excessive bleeding after using Xarelto, your injuries may be the result of a drug manufacturer's negligence. To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb Legal have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.