Doctors prescribe Bayer’s billion-dollar blood thinner Xarelto to prevent blood clots and protect people from strokes. But the drug may also cause irreversible internal bleeding that can lead to hospitalization and death. Lawsuits filed against Bayer claim the company did not warn the public and want the drug removed from the market.

What is Xarelto?

Xarelto (rivaroxaban) is one of the newest anticoagulants – more commonly known as blood thinners. The drug is an oral medication developed by Bayer and Johnson & Johnson’s New Jersey-based unit, Janssen Pharmaceuticals. Blood thinners prevent dangerous blood clots that can obstruct the blood flow to the vital organs. Unlike older anticoagulants that require doctors to prescribe specific doses for each individual, Xarelto belongs to a new type of oral anticoagulant that is prescribed in one uniform dose.

The Food and Drug Administration (FDA) approved Xarelto for use in patients who have had knee or hip replacement surgery to reduce the risk of blood clots, reducing the risk of stroke in people with AF. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

One of the most severe side effects of Xarelto is uncontrolled bleeding. When bleeding occurs near a major organ, such as the brain, lungs or kidneys, blood flow to that organ is interrupted, causing it to lose some or all of its functionality. Also, pools of blood may form within the body and can cause other severe health risks. Because Xarelto prevents clotting, the hemorrhaging will continue until the drug is flushed out of the system.

Xarelto vs. Pradaxa

Another better-known oral anticoagulant is the drug Pradaxa (dabigatran etexilate), manufactured by Bayer’s competitor, Boehringer-Ingelheim. Xarelto and Pradaxa are similar, but they work in different ways. Xarelto inhibits a protein involved in the coagulation process called Factor Xa, which interrupts the blood-clotting process and prevents another protein, thrombin, from forming. Pradaxa directly inhibits thrombin from forming.

Current Anticoagulant Market

$ Billion

The current market for anticoagulants is estimated to be worth $10 billion, and many companies are developing newer drugs to get a piece of this market share. Previously, warfarin (Coumadin, Jantoven) was the industry standard anticoagulant. Because warfarin requires changes in diet and lifestyle, regular checkups, and has a risk of brain hemorrhage, drug companies developed and marketed oral medicines like Xarelto and Pradaxa as safer, more convenient alternatives.

Higher Per-Patient Cost

$ Per Year

Although newer anticoagulants like Xarelto and Pradaxa are helpful to numerous patients, they are more costly than warfarin. Xarelto costs about $3,000 a year compared with $200 for warfarin. These drugs do not require frequent doctor checkups and have a uniform, “one-size-fits-all” dose. They can also have some very dangerous side effects that may lead to lawsuits.

Xarelto Uses and Clinical Studies

Original FDA Approval

Xarelto’s original FDA-approved use was as a blood thinner for patients recovering from knee or hip replacement surgery. Since then, the agency approved the drug to blood clots in patients with irregular heartbeat (atrial fibrillation) and to prevent reoccurring blood clots despite their own panel's disapproval.

Comparison to Warfarin

In 2011, the New England Journal of Medicine published the results of the ROCKET AF study that compared Xarelto to warfarin – a drug used for over 50 years – in patients with AF. The FDA said the study failed to show that Xarelto was more effective than warfarin. The drug is also known to cause more abdominal bleeding than warfarin.

No Antidote

While all blood thinners carry the risk of internal bleeding, older drugs like warfarin have emergency antidotes to prevent serious harm. Xarelto does not have an antidote, and the drug cannot be flushed out of the system through dialysis. People who suffer bleeding can end up hospitalized, and the bleed may be fatal.

Side Effects of Xarelto

One of the most dangerous side effects is bleeding. Xarelto has no known antidote to stop incontrollable bleeds, while warfarin does, and this makes it difficult for doctors to treat patients. The drug’s manufacturers have yet to release information for doctors on how to treat this problem. Unfortunately, this leads to a number of deaths in emergency rooms.

This blood thinner also has a number other serious side effects. For instance, although the medication is supposed to stop blood clots and prevent heart attacks, information gathered from reports of FDA adverse events show that some patients may actually be at increased risk for serious clots. Patients who had hip or knee replacement surgery had the highest risk, according to the Institute for Safe Medication Practices (ISMP). These clots may trigger strokes or heart attacks if they travel to the brain.

Patients who have spinal injections or other procedures are also at increased risk for developing blood clots in the spine that can cause permanent paralysis.

In general, Xarelto's side effects include:

Abdominal Bleeding

Brain Hemorrhage

Abnormal Liver Function

Reduced Platelet Levels

Studies Link Xarelto to Wound Infections, Complications

Orthopedic surgeons across the country observed that among their patients who take Xarelto after hip- or knee-replacement surgery may end up back in the operating room to remove implants and undergo intense antibiotic therapy for weeks and even months. The cause: serious wound infections and leakage. Surgeons who noticed the effects started assessing the risk.

One of the first published studies linking the blood thinner to these new complications appeared in the Journal of Bone and Joint Surgery in 2012. Researchers followed more than 13,000 people after hip or knee surgery – people who took either Xarelto or heparin. Those in the Xarelto group had nearly four times the risk of wound complications.

A British study presented at the annual meeting of the American Academy of Orthopaedic Surgeons in 2012 showed that people who took Xarleto had a significant return-to-surgery rate within 30 days. Doctors in the study stopped prescribing the drug when "large, fresh wounds" were involved. Instead, they switched patients to tinzaparin, an older anticoagulant.

Other studies show the infection rate as even higher, leading some surgeons to abandon the use of the drug altogether. Attorneys say this new complication could lead to more legal battles.

Potential Reactions

Doctors recommend that patients with liver or kidney problems, as well as those who are pregnant, breastfeeding or planning to breastfeed should not take Xarelto. In addition, people who are on Xarelto and have spinal injections, epidurals or surgery have increased risk of forming a blood clot in the spine that can cause paralysis. The risk of spinal clotting is increased for people who take NSAIDS like aspirin and ibuprofen (Advil) or people who have a history of spinal problems and surgery.

Xarelto also has an extensive list of drug interactions that can cause serious problems, including increased bleeding risk.

Drugs that may adversely react with Xarelto include:

  • Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol)
  • Indinavir (Crixivan)
  • Itraconazole (Onmel, Sporanox)
  • Ketoconazole (Nizoral)
  • Lopinavir/ritonavir (Kaletra)
  • Phenobarbital (Solfoton)
  • Phenytoin (Dilantin-125, Dilantin)
  • Rifampin (Rifater, Rifamate, Rimactane, Rifadin)
  • Ritonavir (Norvir)
  • St. John’s wort (Hypericum perforatum)

Phase III Study

In a Phase III study intended to examine the drug’s safety, 73 percent of the 16,041 participants who took at least one dose of Xarelto experienced side effects. Some of the most prominent serious side effects were anemia and bleeding events. People who took a higher dose were more likely to suffer from bleeding.

In addition to these side effects and drug interactions, the FDA released a warning that patients who suddenly stop taking Xarelto can be at increased risk for developing blood clots.

Participants of the study also suffered from these side effects:
Dizziness Hemorrhaging in the eye Headache
Rapid heartbeat Low blood pressure Bruising
Rectal bleeding Gastrointestinal and Urogenital bleeding Nose bleeds
Vomiting Muscle pain Edema

Xarelto Lawsuits

Legal Options

Legal Options for Compensation

People who took Xarelto and suffered from irreversible bleeding filed lawsuits for compensation for medical bills, injuries and emotional trauma. Families of people whose bleeds were fatal also sought justice for their loved ones. Xarelto’s predecessor, Pradaxa, has already led to a number of lawsuits filed against its manufacturer because of complications such as excessive bleeding and death. Its maker paid $650 million dollars to settle about 4,000 claims.

Holding the Manufacturers Accountable

Some of the lawsuits filed against Bayer and Johnson & Johnson say that the company failed to warn the public of the dangers of irreversible bleeding. Many of those injured were rushed to the hospital with severe bleeding. Lawsuits claim the drug's makers misrepresented the safety and effectiveness of the drug. Those currently involved in litigation allege the companies continued to sell Xarelto even when they knew it was dangerous.

Gavel in Courthouse

Vanessa Blanco

Patient Advocate vblanco@drugwatch.com
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If you or a loved one were affected by uncontrolled bleeding or any of the other dangerous side effects of Xarelto, our patient advocates can assist you.

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  7. Janssen Pharmaceuticals. (2012). Xarelto. Retrieved from https://www.xarelto-us.com/
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