What is Xarelto?
Xarelto is the prescription brand name of the chemical rivaroxaban, which is prescribed as a blood thinner. Blood thinners prevent and treat clots which form in the blood due to a variety of conditions, and have been around for a long time. Xarelto is a relatively new blood thinner which was first approved by the Food and Drug Administration (FDA) in July 2011.
Uses of Xarelto
Xarelto is currently approved by the FDA to treat or prevent two main health problems. It may also be used “off label” by certain doctors, meaning that Xarelto might be prescribed in other circumstances which are not directly listed on the medication's label.
Deep Vein Thrombosis (DVT)
Deep Vein Thrombosis (DVT) is a term for a dangerous condition in which blood clots form in one of the “deep” veins in your body. It is more likely to occur when an individual is unable to move for long periods of time, like when they are recovering from an accident or have just undergone surgery. In this case, Xarelto is sometimes prescribed after surgeries (particularly knee or hip replacement surgery) to prevent such clots from occurring. These clots are particularly dangerous because they can travel from the source to the lung, which blocks blood flow in a condition called a “pulmonary embolism.”
Xarelto is also commonly prescribed to patients who have atrial fibrillation, a chronic heart condition in which the heart's electrical rhythm is disrupted and abnormal. This irregular rhythm can cause blood clots to form around the heart, which may travel to the brain and cause stroke and even death. Xarelto is often prescribed to manage this condition by thinning the blood and reducing the chance that a clot may form.
How Blood Thinners Work in the Body
Blood thinners are a common class of drugs which help prevent strokes and heart attacks by keeping blood clots from forming in the body. There are two classes of blood thinners: anticoagulants and antiplatelets. Anticoagulants, such as heparin, warfarin, and Xarelto, work on chemical processes in the body to reduce the body's ability to form clots. Each anticoagulant works slightly differently by focusing on a different chemical reaction involved in the formation of blood clots. Antiplatelet drugs, including aspirin, work by preventing platelets in the blood from clumping together.
Xarelto's Mechanism of Action
The formation of a simple blood clot is a long and complex process that requires multiple cascading chemical reactions which occur in a certain succession. Disrupting just one of those many processes can prevent blood clots from forming. Often, blood clots can be lifesaving, for example when your body stops a wound from bleeding by clotting at the wound's opening. However, blood clots which form in the body without a purpose can clog veins and arteries and lead to severe, sometimes fatal, consequences.
The chemical compound in Xarelto, rivaroxaban, works in a unique way by binding with a certain compound in the blood known as “Factor Xa” or FXa. FXa is necessary to produce the enzyme called thrombin which is essential to blood clotting. Thrombin works with another protein, fibrinogen, to create fibers which bond blood cells and platelets together, forming a clot. By blocking FXa, Xarelto effectively blocks the production of thrombin, putting it into yet another class of specific drugs called an “anti-thrombotic.”
Development of Xarelto
Xarelto was originally developed by Bayer, a major pharmaceutical company, through a program with the company Johnson & Johnson. In 2007, Bayer submitted an application to be able to market the drug in Europe and was approved in 2008. However, in the United States, Bayers application to the FDA to market the drug was denied in 2009 due to questions that the agency had about the drug's side effects.
Later in the year, Bayer completed new clinical research which was presented to the FDA, which finally approved the drug in July of 2011, specifically “for prevention and treatment of prophylaxis of deep vein thrombosis (DVT) following orthopedic surgery.” This meant that Xarelto could be prescribed to patients to prevent blood clots during recovery from hip and knee replacement surgeries. Later that same year, in November, the drug was additionally approved to prevent blood clots and strokes in patients suffering from the chronic heart condition, atrial fibrillation.
Since its approval in the United States, Bayer has successfully applied for the right to market the drug in 110 countries worldwide. Today, the drug's marketing is overseen and implemented by Janssen Pharmaceuticals. According to Johnson & Johnson's annual report, in 2016, total profits accrued from Xarelto totaled $2.2 billion.
Common Side Effects
After a prescription medication gets approved by the FDA and goes through all the necessary testing in clinical trials, it is recommended for particular conditions and always includes a comprehensive label. This label describes all reported common and uncommon side effects which were experienced by those who took the drug during the clinical trial. Often, this list is very long because it includes every health problem that was experienced by participants, whether or not that problem was related to the drug or not because it is often impossible to ascertain direct cause and effect.
Even when you are provided with a paper copy of the information on a prescription drug, the doctor has a responsibility to explain all the risks and side effects associated with it in a way that you can understand. Often, there are medical names for side effects which may not be immediately understood by a patient. In addition, patients have a right to understand the different risks and side effects associated with different kinds of drugs, especially when there are many options for prescriptions that might work effectively as a blood thinner.
Common side effects associated with Xarelto, which can range from moderate to severe, include:
- Back pain
- Bleeding gums, or coughing up blood
- Bloody, tarry, or black stools or incontinence
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- Difficulty with breathing or swallowing
- Increased menstrual flow or vaginal bleeding
- Nosebleeds or prolonged bleeding from minor cuts
- Leg weakness, numbness, paralysis, dizziness, or headaches
- Red or dark brown urine
- Vomiting blood or material that looks like coffee grounds
Less common but reported symptoms include fainting, pain in the arms and legs, and secretion of clear or yellowish liquid from wounds. Rare symptoms of Xarelto include painful or burning sensations while urinating. In addition to these symptoms, there is also a long list of symptoms which have an unknown rate of occurrence. Many of these symptoms, though not originally listed on the label when first approved after clinical trials, have been reported by those who have been prescribed the drug. These include a huge range of physical reactions:
- Lower back or side pain
- Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- Red skin lesions, often with a purple center
- Red, irritated or yellow eyes or skin, blurred vision
- Severe headache, fever, chills, nausea or vomiting
- Sore throat, sores, ulcers, or white spots in the mouth or on the lips, unpleasant breath odor, loss of appetite
- Tightness in the chest, fast or irregular heartbeat
- Unusual bleeding or bruising
- Unusual general feeling of tiredness or weakness
- Abdominal or stomach pain or swelling
- Blistering, peeling, or loosening of the skin, hives, itching, or skin rash
- Clay-colored stools or diarrhea
- Cough or hoarseness
- Dark urine
- Joint or muscle pain
Any of these side effects can be troubling, especially if they are causing the patient pain for an extended period of time. If someone experiences one or more of these side effects, it is advised that they call their doctor to ensure that there are no underlying or concurrent health issues that should be addressed. However, one of the most serious and life-threatening conditions resulting from this particular blood thinner is uncontrolled and spontaneous bleeding.
The Risk of Uncontrolled Bleeding
While blood thinners perform an important function for people at particular risk of developing dangerous blood clots, they can also put patients at severe risk. In certain cases, Xarelto can cause uncontrolled internal bleeding, in which the body is unable to form the necessary clots which seal the wound. Uncontrolled bleeding is always serious and should be addressed immediately, but the danger it poses can range from mild to severe. If the bleeding occurs near a major organ, such as the brain, heart, lungs, kidneys, or liver, blood flow, and therefore oxygen, may not be able to reach the organ which can cause organ failure. Another consideration is that the blood leaking from the veins or arteries may pool in the body. If the bleeding occurs in the brain, it may result quickly in permanent brain damage or death.
A risk of uncontrolled bleeding is a side effect shared by most blood thinning medications. However, Xarelto, which is a fairly new brand of blood thinner, is unique in that it does not have an antidote or “reversal agent.” This means that, in the case of an unexpected bleed, there is no way to reverse the process of the medication so that the blood can clot and stall the bleeding. In the case of almost every other blood thinner on the market, there are antidotes which can be used in the event of an emergency.
Xarelto vs. Warfarin
For many decades, the most common blood thinner prescribed to patients at risk of stroke or pulmonary embolism was warfarin, a generic drug which has an antidote or reversal agent in the event of an emergency involving uncontrolled bleeding. In the mid-2000s, however, when Xarelto was being developed, Bayer Pharmaceuticals had to figure out a way to make their product stand out. The FDA will only approve new drugs if they have added benefits in comparison to previous versions of the drug. In the case of Xarelto, Bayer argued that it was superior because it had three distinct added benefits: it required no dietary restrictions, its dose did not have to be frequently adjusted, and it did not require frequent blood monitoring. Warfarin required all of these three factors.
However, regardless of these claims of technical improvement, the basic function of the drug is identical, and multiple studies have confirmed that Xarelto and warfarin have the same rates of success and associated mortality. Xarelto was aggressively marketed for a period of time as being more effective than warfarin, but this claim has not been held up in multiple studies. It is important to note that a year's supply, on average, of warfarin, costs only $200, while the same year's supply of Xarelto costs around $3000.
Unlike Xarelto, warfarin has a simple antidote which reverses the blood thinning agents of the drug. Doctors simply give the patient vitamin K or a number of other chemicals to stop the process. With Xarelto, there is no simple way to stop uncontrolled bleeding, leading to a high frequency of adverse events. In addition, in Bayer's direct-to-consumer advertising, there was no acknowledgment or information about how the drug's effects may be irreversible, unlike other drugs. In fact, in 2013, the FDA sent a letter to Janssen, the marketing company which manages how Xarelto is advertised and told them that to stop running a certain advertisement because it was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.”
When patients are prescribed drugs by their doctor, they must place their faith in both the physician and the pharmaceutical company which manufactures, distributes, and markets the drug to hospitals and patients. Unfortunately, the profits associated with drug sales, especially for drugs which are frequently prescribed such as blood thinners, can override a pharmaceutical company's dedication to safety.
Research Supporting Lawsuits against Xarelto
Since Xarelto was introduced into the American market in 2011, there have been a growing number of complaints about adverse events associated with the drug. According to a recent analysis by the Institute for Safe Medication Practices (ISMP), Xarelto is one of the drugs for which the highest number of complaints are submitted to the FDA. Their quarterly report states, “Anticoagulant drugs–led by rivaroxaban (XARELTO)–accounted for 21,996 reports of severe injuries in the U.S., including 3,018 reported deaths, according to our analysis of 2016 FDA adverse event data.” 15,043 of the 21,996 severe injuries caused by anticoagulants were the result of Xarelto.
The ISMP also found that, according to the Center for Disease Control data, anticoagulants “accounted for more emergency department (ED) visits for outpatient adverse effects than any other class of drugs in therapeutic use, including opioids (non-abuse visits), antibiotics, and diabetes drugs.” This makes the new class of anticoagulant drugs, such as Xarelto, one of the most dangerous groups of prescription medication on the market. These drugs are still prescribed to patients across the US today, and there has been no recall.
Xarelto Multidistrict Litigation
Today, more than 17,000 individual lawsuits have been filed against Bayer, the manufacturer of Xarelto, for their failure to advise patients and doctors about the severe, sometimes fatal, side effects of the drug. Even when hundreds of adverse events reporting uncontrolled bleeding and associated fatalities began pouring in, the drug company still failed to issue any sort of warning to potential patients. The plaintiffs additionally claim that Xarelto was falsely marketed as an improvement to the previously prescribed, safer anticoagulant, warfarin. They point to early studies which show that, while Xarelto had a marginally higher rate of success in terms of preventing Deep Vein Thrombosis (DVT), it also posed a significantly greater risk for uncontrolled bleeding without an antidote.
More than 7,000 Xarelto claims filed in federal courts throughout the country have been added to a multidistrict litigation (MDL) in Louisiana federal court. In MDLs, litigation tends to move quicker because participants' cases are consolidated so that pretrial evidence, arguments, and scientific research are compiled using shared resources. The participants retain their own attorney and have a separate trial.
One month after a consolidation of federal cases, nearly 1,500 Xarelto lawsuits in Pennsylvania were consolidated in the Philadelphia Court of Common Pleas under Pennsylvania's mass tort program. Pennsylvania's complaints are primarily filed against Bayer Healthcare Pharmaceuticals, which produces Xarelto, and Johnson & Johnson's subsidiary, Janssen Pharmaceuticals, which markets it. Pennsylvania trials are set to begin in August 2017
Joining Xarelto Litigation against Bayer
If you have experienced uncontrolled bleeding of any kind after taking the prescription medication Xarelto, or if your loved one passed away due to effects of the drug, you may be entitled to compensation. If you choose to file a lawsuit against Bayer, your case will join thousands of others to hold this company responsible for their failure to inform consumers about serious risks associated with their drug. Unlike a class action suit, however, your case will remain separate and your compensation will be decided individually.
Unfortunately, drug companies are multi-billion dollar, international enterprises, with entire teams of lawyers available to make their case. Often, pharmaceutical companies are aware of the possibility of lawsuits but choose to act questionably in any case because they know their profits will exceed the cost of associated litigation. In order to break this pattern and to send a message, it is important to take legal action. You will not have to pay anything to participate in this litigation unless you receive compensation for your injuries. To get started, call The Brod L:aw Firm 24 hours at 1-888-435-7946 or contact us online for a free consultation.