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.
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.
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.
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.
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’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.
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.
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.
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.
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.
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|
Knowledge is key when attempting to prevent blood clots. Each treatment carries benefits and risks. Drugwatch provides comprehensive overviews of anticoagulants like Pradaxa, Eliquis and warfarin. The National Heart, Lung, and Blood Institute and the Agency for Healthcare Research and Quality also provide a wealth of information available online.
People taking Xarelto or other blood thinners should also follow some basic safety tips to lower their risk for bleeding events.
Support is also one of the most important resources for people taking Xarelto or other blood thinners. Friends, family and other caregivers often help patients attend doctor visits, blood monitoring appointments and other important activities. Caregivers can become fatigued though. Fortunately, there are many resources available online and support groups for caregivers can be found in many communities.
Xarelto is not the only treatment available for people with atrial fibrillation, for reducing the risk of blood clots after hip or knee surgery or for preventing reoccurring blood clots. Other anticoagulants like warfarin can reduce the risk of blood clots too.
Doctors can also prescribe beta blockers, calcium channel blockers or digitalis to help control the rate at which the heart beats in people with atrial fibrillation. Patients with irregular heartbeat may also be able to restore a normal heart rhythm through a treatment called rhythm control. Multiple drugs may help control heart rhythm too.
Patients can also reduce the risk of blood clots by treating conditions that increase the risk of clots like high blood pressure, high cholesterol or an overactive thyroid. Eating a healthy diet, reducing sodium intake, reducing stress and quitting smoking may also help reduce the risk of blood clots.
When blood thinners don’t work, doctors may insert devices called intra vena cava filters that physically block a clot from reaching the heart or lungs, but the filters carry risks and are generally a last resort option.
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.
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.