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.
Bayer and J&J advertise that Xarelto is safe and more convenient than warfarin, but the drug comes with a very dangerous side effect: internal bleeding that can be fatal.
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. For example, warfarin, one of the oldest blood thinners may also cause bleeding, but ER doctors can use a vitamin K antidote to 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.
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 specific proteins in the blood that normally start the clotting process and blocks them.
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:
- Bleeding from the rectum
- Intestinal or abdominal bleeds
- Hemorrhaging
- Bleeding in the brain
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
This blood thinner also has the U.S. Food and Drug Administration’s (FDA) 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.
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.
If you or a loved one took Xarelto and suffered from internal bleeding, Drugwatch’s Patient Advocates can answer questions about side effects and legal options and get you the help you need.
