Xarelto, a powerful new blood-thinning drug, has been linked to an increased risk of severe bleeding. Lawsuits accuse drug-makers of failing to warn that it lacks a reversal agent, which makes hard to stop bleeding in an emergency. Unfortunately, bleeding is one of the most common side effects
Over 3,000 Xarelto Lawsuits Filed
Thousands of lawsuits have been filed by people who took Xarelto and were injured by severe bleeding. All of these lawsuits accuse the manufacturers, Janssen Pharmaceuticals and Bayer HealthCare, of failing to warn that Xarelto lacks a reversal agent, which could increase the risk of uncontrollable bleeding in an emergency. Despite this serious problem, Xarelto was advertised as superior to Coumadin (warfarin).
Lawsuits Centralized in Federal Court
In December 2014, federal judges decided to centralize all of the lawsuits into one federal court in Louisiana. One year later, about 2,800 lawsuits were centralized in the court (Multi-District Litigation No. 2592) under Judge Eldon E. Fallon. Over 500 additional lawsuit are pending in another court in Pennsylvania.
Xarelto and Bleeding
Blood-thinning medications, such as Xarelto (rivaroxaban), prevent blood clots from forming. Xarelto inhibits the enzyme factor Xa. Patients who are on Xarelto are more likely to develop internal bleeding. When bleeding occurs, it is difficult to stop.
What Percentage of Xarelto Patients Have Bleeding?
The safety of Xarelto compared to warfarin was established in the ROCKET AF clinical trial, which involved over 7,000 people. Researchers found the following rates of internal bleeding:
- Major bleeding: Xarelto (5.6%) – Warfarin (5.4%)
- Bleeding in a critical organ: Xarelto (1.3%) – Warfarin (1.9%)
- Fatal bleeding: Xarelto (0.4%) – Warfarin (0.8%)
- Bleeding resulting in transfusion: Xarelto (2.6%) – Warfarin (2.1%)
- Gastrointestinal (GI) bleeding: Xarelto (3.1%) – Warfarin (2%)
Xarelto Bleeding Study Conclusions Based on Defective Devices
The study concluded that Xarelto and warfarin had comparable rates of bleeding. However, the results may have been skewed in Xarelto’s favor because patients on warfarin were given defective INR-testing devices. The FDA warned about problems with the devices in 2005, but they were still used in the ROCKET-AF study when it opened enrollment in 2006.
Does Xarelto Have a Reversal Agent?
When Xarelto was approved in 2011, it had no reversal agent. It was not until early 2016 that Portola Pharmaceuticals began marketing a reversal agent called andexanet alfa.
Xarelto is a popular alternative to Coumadin (warfarin), a blood-thinning drug that has been on the market since the 1950s. Warfarin can be deactivated with a dose of Vitamin K, but it doesn’t work with Xarelto. In fact, because Xarelto binds so tightly to proteins in the bloodstream, not even dialysis (mechanically cleaning the blood) can reverse its blood-thinning effects.
Internal bleeding occurs when blood vessels (veins or arteries) are damaged and blood escapes the circulatory system. Normally, damaged walls of blood vessels release enzymes that trigger a series of events culminating in the formation of a clot, which clogs the vessel, stops the bleeding, and allows the damage to heal. Xarelto blocks this enzyme and changes blood chemistry to prevent clots from forming.
Patients on Xarelto should avoid activities that increase the risk of falls or injuries. They should also take steps to create a safe environment at home, such as removing scatter rugs or other hazards.
Serious bleeding is a medical emergency that must be controlled immediately. Direct pressure is the most effective way to stop bleeding. Pressure should be applied directly over the wound and held firmly to “seal off” the broken blood vessel, but not so tight that circulation is cut off to the rest of the limb.
Symptoms of Internal Bleeding
Internal bleeding can occur in tissues, muscles, joints, organs, or cavities inside the body. The symptoms depend on where the bleeding is located and how much blood has been lost. These symptoms may include:
- Bruising that occurs easily or takes longer than normal to heal
- Red or dark brown urine
- Red or black bowel motions
- Nosebleeds — particularly when they occur more frequently or take longer than normal to stop
- Trouble breathing or swallowing
- Coughing up blood
- Heavier than usual menstrual periods
- Bleeding from cuts, wounds and scrapes that takes too long to stop
- Dark or blood-stained vomit
- Severe headache or dizziness
- Unexplained shock, paleness or weakness
- Unexplained pain, swelling or discomfort
Many healthy adults can lose a pint of blood before they show signs of hypovolemic shock, which is a life-threatening complication involving rapid heartbeat, low blood pressure, cold body temperature, and confusion. During shock, there is not enough blood in the body and major organs start to shut down. Blood pressure plummets and cuts off circulation to organs and tissues. This can lead to complications, such as:
- Kidney failure
- Brain damage
- Gangrene of arms and legs (may require amputation)
- Heart attack
- Organ damage