Xarelto has several side effects, but the most dangerous is internal bleeding that can be fatal. People who suffered internal bleeds filed lawsuits against Bayer claiming the company did not warn of the risk.
Doctors prescribe the blood thinner Xarelto (rivaroxaban) to patients to reduce the risk of blood clots that may cause strokes. It is popular because it does not require patients to have special diets or have blood tests to determine the dose like warfarin, one of the oldest blood thinners. The drug is manufactured by Bayer and marketed by Johnson & Johnson’s Janssen Pharmaceuticals unit. In 2013, Bayer made $1.3 billion in sales from the drug, and will make billions more in the next few years.
While patients taking the blood thinner Xarelto may suffer from common side effects like itching, easy bruising, numbness and muscle pain, the risk of uncontrollable bleeding events poses the greatest threat. So far, about 4,500 people filed lawsuits against Bayer because of bleeding adverse events they say were caused by Xarelto.
Xarelto’s Most Dangerous Side Effect: Internal Bleeding
Bayer and J&J advertise that Xarelto is safe and more convenient than warfarin, but taking the drug leaves users vulnerable to internal bleeding that can be fatal.
In 2014, The Institute for Safe Medicine Practices (ISMP) reported that 3,331 people suffered adverse events from Xarelto. Of these people, 1,647 suffered hemorrhagic bleeding. In 2013, German regulators reported the number of deaths attributed to the drug rose from 2012.
While the risk of bleeding exists with all blood thinners, Xarelto is more dangerous because it does not have an antidote or reversal agent. Dialysis is also ineffective for flushing out the drug from the symptom. On contrast, warfarin, one of the oldest blood thinners may also cause bleeding, but ER doctors can use a vitamin K antidote to stop the bleeding. Warfarin also has a few other options that help stop bleeds. According to one lawsuit, a man died of parenchymal hemorrhage, a brain bleed or intraparenchymal hemorrhage, because he was on Xarelto and ER doctors could not stop the bleeding.
People who ended up in the hospital with severe or fatal bleeds filed lawsuits against Bayer claiming the company released a dangerous drug and misled the public about its safety.
What are Common Xarelto Bleeding Symptoms?
Common Xarelto bleeding symptoms may go unnoticed for some time, as is the case with certain internal bleeding wounds, or may be clearly indicated by intense pain and hemorrhaging. Taking certain drugs at the same time as Xarelto, such non-steroidal anti-inflammatory drugs or aspirin, increases the risk of bleeding.
Bleeding symptoms which may be related to Xarelto use include:
- Cool and sweaty skin
- Headaches, confusion, dizziness or general weakness
- Low blood pressure
- Frequent nose bleeds or gum bleeding
- Blood in urine
- Intense pain
- Coughing up blood
- Vomiting, lethargy, seizure and unconsciousness
In addition, bleeding caused by Xarelto may lead to a life-threatening condition called hypovolemic shock. This type of shock happens when the body loses too much blood. Doctors typically treat hypovolemic shock with emergency infusions of fluids. If an individual does not get treatment immediately, the condition can lead to death.
How Does Xarelto Cause Bleeding?
Because the drug is designed to stop the blood from clotting, there is a possibility that any injury – even a minor one – can be very dangerous. The blood thinner works by affecting a specific protein in the blood called factor Xa that normally starts the clotting process. By blocking factor Xa, Xarelto stops the production of a clotting enzyme called thrombin and prevents clots from forming.
It can take as long as 24 hours for the drug to be flushed out of the system. Older adults have a more difficult time flushing the drug, and the anticoagulation effect lasts longer in their bodies. This puts seniors at increased risk for possibly fatal bleeds, especially if they fall or hit their heads.
Because there is no antidote, doctors have no way of immediately stopping the bleed, and the situation in the hospital can be dire. As the side effects mount, some doctors are growing wary of using it.
The drug can cause many types of bleeding, including internal and abdominal bleeding that may go unnoticed for some time. Xarelto users may begin to notice bleeding side effects such as bleeding from the rectum and severe hemorrhaging.
Patients who are going to have surgery must stop taking the drug at least 24 hours before the procedure to avoid complications. In addition, pregnant women may suffer hemorrhaging while taking Xarelto.
Compared to warfarin, Xarelto also causes more abdominal bleeding.
Black Box Warning For Spinal Bleeding
In August 2013, the U.S. Food and Drug Administration (FDA) added a black box warning — its most severe label warning — for dangerous spinal bleeds called epidural or spinal hematomas. Hematomas are pools of blood that occur outside of blood vessels. Blood pooling in the spine can cause permanent paralysis.
People are at greater risk if they:
- Use epidural catheters
- Use other drugs that can affect the clotting process, such as NSAIDs or platelet inhibitors
- Have a history of spinal trauma
- Have a history of spinal surgery
The warning also cautions against any spinal procedures in patients who take Bayer’s drug. In March 2014, it updated the warning to add more information for health care providers on limiting the risk of spinal bleeding. Some procedures which may put patients at risk include spinal taps, spinal punctures, epidurals and any kind of spinal injections.
Reducing Xarelto Bleeding Risk
According to NPS Medicinewise, a non-profit health care organization, there are a few things people who take Xarelto can do to minimize the risk of bleeding.
Tips to reduce complications from Xarelto bleeding include:
- Seek emergency help for any signs of bleeding such as: coughing blood, blood in urine or a bruise after a fall that isn’t healing
- Report any falls to a doctor, even if there are no signs of bleeding
- Avoid activities that can cause injury such as contact sports, wear protection when handling sharp objects and use an electric shaver
- Disclose all medications to doctors, some may increase bleeding risk
- Let health providers know about Xarelto use prior to surgeries or dental prodecures
Internal Bleeding Lawsuits
One of the biggest concerns with Xarelto is that it can cause irreversible bleeds that can be fatal. Trips to the hospital are costly and cause a good deal of emotional trauma for the patient and family members.
Victims filed the first U.S. lawsuits in June 2014.
Virginia Stuntebeck filed a lawsuit against Bayer in Philadelphia Courts after she suffered severe internal bleeding caused by the company’s blood thinner. In February 2013, she ended up in the hospital with severe gastrointestinal bleeding.
According to the complaint, Stuntebeck alleges that Bayer and Johnson & Johnson did not properly warn the public about the risks and should never have sold the drug.
“As the manufacturers and distributors of Xarelto, defendants knew or should have known that Xarelto use was associated with irreversible bleeds,” the complaint said.
A similar drug, Pradaxa, also caused irreversible bleeding and its manufacturer, Boehringer Ingelheim paid $650 million to settle thousands of cases.
Meanwhile, Bayer maintains that the drug is safe.