Xarelto is considered a factor xa inhibitor. Basically what this means is that when the blood is going to coagulate, it goes through a series of chemical reactions. One of those reactions is the production of factor xa. By inhibiting this step, Xarelto ensures that blood clots don’t form.
This is a slight variation of the drug warfarin (brand name Coumadin). Warfarin does essentially the same thing, but instead of blocking factor xa, it blocks the formation of vitamin K dependent clotting factors.
Xarelto’s Beginnings
Many drugs have a long history of research before the public is even made aware of them. Xarelto is no different. The scientists at Bayer Healthcare saw the need for an improved oral anticoagulant, so they began development on a drug that would act as a Factor Xa inhibitor. By the year 2008, they had their product and found FDA approval for clinical trials.
During clinical trials the drug is moved from testing on animals, to testing on people. Often done with the help of volunteers (in exchange for free treatment), or done on participants who are paid for their time, these trials help to further flush out any rare side effects that the drug may cause.
By 2011, the FDA had sufficient evidence that the benefits of the drug outweighed the risks of taking it.
Xarelto’s Approval
In July 2011, the FDA approved the drug for use in patients who had recently undergone knee or hip surgery. These patients are often on restricted mobility. Accompany that with the fact that there may have been some trauma to the blood vessels, and their risk of blood clots is heightened. Xarelto blocks the enzyme Factor Xa inhibiting the blood from clotting.
In November 2011, the FDA approved Xarelto to prevent blood clots in people who suffer from abnormal heart beats. When a person suffers from A Fib, the blood can move more slowly through the heart chambers. This can lead to clotting that eventually could lead to stroke.
2012 saw approval for the treatment of recurring blood clots, and in 2013 the drug was approved for the treatment of stent thrombosis for those who suffer from acute coronary syndrome.
Xarelto Popularity
Millions of dollars translate into just over one million prescriptions each quarter. In the three month period that composed the third quarter of 2013, more than 1 million prescriptions for the drug were written, that is increased from 832,000 in the second quarter. As more and more people are prescribed the drug, more and more are put at risk of developing severe side effects.
The primary reason that Xarelto is so popular is that they have a good advertising campaign. There is a lot of push behind the drug, and that translates to more people purchasing it. The other reason is that one of the alternatives, Coumadin, is hard to get the dosage properly. With Coumadin the patient needs to have regular blood tests to make sure everything is going well. Those tests are not necessary with Xarelto.
Side Effects
While the drug is popular, in part due to aggressive marketing and in part due to little competition (Pradaxa, Eliquis, and Coumadin are the competitors), it does come with its share of side effects. Some of the less severe side effects include:
- Muscle and Joint Pain
- Itchy Skin
- Throat Pain
- Indigestion
- Many More
These side effects should decrease over time as the body becomes used to the new drug. However, there are many other severe side effects that could be potentially fatal. They include:
- Hemorrhaging
- Brain Hemorrhage
- Abdominal Hemorrhage
- Stevens-Johnson Syndrome
- Jaundice
- Abnormal Liver Functions
Atrial Fibrillation
A study published in 2011 looked at the efficacy of Xarelto when taken to help prevent blood clots in those suffering from A Fib. This study compared over 14,000 patients; some were taking Xarelto and others were taking warfarin. The study found that both drugs worked equally well, and while Xarelto carried less risk (not to be confused with no risk) of bleeding in the brain, both drugs made the patients equally susceptible to bleeding.
The drug manufacturers used this information to petition the FDA to approve literature saying that Xarelto was superior to warfarin. However, that request was denied due to the fact that both drugs worked equally well. It is important to note that this study was funded by Johnson & Johnson and Bayer, the two companies selling the drug in the US.
Pulmonary Embolism
In 2012 a study was published looking at Xarelto and how well it worked to treat pulmonary embolism. This study looked at over 4,800 individuals and monitored their progress while taking the drug.
The results were that over 1% of the people taking the drug suffered from bleeding. When extrapolated to the millions of people currently taking Xarelto, this means that for every 1 million prescriptions, there will be over 10,000 who suffer from internal bleeding. Again, this study was funded by Bayer and Janssen Pharmaceuticals./su_spoiler]
Gastrointestinal Bleeding
While Xarelto can lead to a number of different bleeding problems, it is often associated with severe gastrointestinal bleeding. This internal hemorrhaging can be triggered by a number of different events, but the outcome is the same. A patient using an anticoagulant drug will be unable to clot the blood and stop the internal bleeding on their own. The result is that the bleeding continues to occur until the drug works its way out of the individual’s system.
Gastrointestinal bleeding isn’t just a straight forward concept either. There are many different types of bleeding that can occur in the abdomen area of the body and they are generally divided into 2 regions: upper gastrointestinal bleeding and lower gastrointestinal bleeding.
The upper region includes the esophagus, the stomach, and the first part of the small intestines. These conditions include tears, ulcers, and cancers. While Xarelto does not inflict the tear, it does prevent the body from healing itself. For those who are suffering from bleeding in the upper region, they may notice severe stomach pains, nausea, and vomiting blood.
The lower region bleeding includes the small intestine, large intestine, rectum and anus. Those who suffer from lower region bleeding may have conditions like polyps, inflammatory bowel disease, cancers, or hemorrhoids. The symptoms include blood in the stool or urine, severe abdominal cramps, and diarrhea.
Most people who are suffering from gastrointestinal bleeding will not have to worry too much about the actual tears or ulcer (unless the underlying cause is a form of cancer or another malady that requires surgery), however, those who are on Xarelto will not be able to stop the bleeding on their own. In fact, even if they are hospitalized many patients require a blood transfusion until the medication has left the body’s system.
Hemorrhaging
Any time that a blood vessel bursts it is said to be hemorrhaging. While that is true in the strictest definition of the term, there is a narrower definition that is used when Xarelto is said to cause hemorrhaging.
In this sense of the term, hemorrhaging pertains primarily to internal bleeding. But not just a little blood, instead it is bleeding that cannot be controlled. As a blood thinner Xarelto prevents the blood from clotting. If a person starts to bleed internally, they won’t be able to clot the blood and stop the bleeding naturally. Knowing the signs and symptoms of hemorrhaging, especially when using a blood thinner like Xarelto, can help save your life.
If a person hemorrhages on the surface, or external hemorrhaging, it is easy to see what is going on. Blood will flow and it will be difficult, or impossible, to get the bleeding to stop. However, internal hemorrhaging is a bit harder to detect, especially since it can occur in many places throughout the body including:
- Bruising
- Kidneys
- Nosebleeds
- Lungs
- Menstrual bleeding
- Gastrointestinal
- Brain hemorrhage
While it is important to know that Xarelto can lead to an increased risk of all of these types of bleeding, the most common that patients have is gastrointestinal bleeding.
When suffering from gastrointestinal bleeding, those taking Xarelto may experience these symptoms:
- Fatigue and Weakness
- Shortness of Breath
- Abdominal Pain
- Red or Black Stools
- Vomiting Blood
If you take Xarelto, and you find that you experience any of these symptoms, you should call your doctor right away to make sure that you are not suffering from an internal hemorrhage. These events can cause serious damage to internal organs, and even with hospitalization can bring a patient close to death.
While a hemorrhage can be something as minor as a bruise (easy bruising is a side effect of this drug) these severe and potentially fatal side effects are referring to other forms of internal bleeding. Xarelto is designed to thin the blood and stop clotting that could lead to stroke and other problems. However, one of the major unintended side effects is that minor internal bleeding (something that people who are not taking a blood thinner would have no problems with) does not stop.
For those who develop internal bleeding while on Xarelto, there is no cure. They can stop taking the drug, but it can take days to weeks for the effects to leave the system. During that time many patients require hospitalization and constant attention so the bleeding does not get out of control.
Xarelto Deaths
Because there is no reversal agent for Xarelto, at least 65 people have died from internal bleeding since the drug found FDA approval in 2011. To make matters worse, Bayer and Johnson & Johnson never fully warned about the possibility of unstoppable internal bleeding. Many of those who have suffered, or the estates of those who have passed away from Xarelto complications, have filed lawsuits against the drug manufacturer and marketers for failure to warn about this deadly side effect.
Xarelto Lawsuits
Virginia Stuntebeck
Virginia Stuntebeck, a resident of Kentucky, filed a lawsuit against Bayer, Janssen, and Johnson & Johnson in February 2014. The claim was that after taking Xarelto for a year and a half, she suffered from gastrointestinal bleeding. The risk of internal bleeding was never fully disclosed.
The drug companies claim that Xarelto is a better choice than warfarin (Coumadin) due to the fact that it is easier to dose, and easier to take. However, the drug manufacturer failed to warn that the drug caused more incidences of gastrointestinal bleeding than those taking warfarin.
Stuntebeck’s lawsuit alleges that the manufacturer should have known there was a risk of internal bleeding, and that risk should have been highlighted in a boxed warning on the drug’s label. However, the company did not fully warn consumers about that risk. The Xarelto lawsuit was filed in the Philadelphia Court of Common Pleas seeking an undisclosed amount.
Della Wise
Della Wise has filed a Xarelto lawsuit over the death of her aunt Mattie Edgin. The lawsuit alleges that Xarelto was pushed through misleading advertising with no regard to accuracy. The suit claims that Mattie is just one of many victims that have suffered because of the claims put forth by Bayer and Janssen Pharmaceuticals.
Xarelto is known to cause gastrointestinal bleeding. However, there is no cure or antidote for those suffering while taking Xarelto. These issues have been known for quite some time, even experienced during the clinical trials of Xarelto (and their leading competitor Pradaxa); however the consumer was never fully warned about the risk.
Xarelto MDL
Because of how many lawsuits have been filed (currently around 50 Xarelto lawsuits from around the country), and because of the similarities among all of these lawsuits, the cases have been centralized to New Orleans. The Multidistrict Litigation (MDL) will be heard by Judge Fallon, and hopefully a settlement will be reached soon.
How an MDL Works
Multidistrict Litigation is actually a commonly used method of streamlining lawsuits. When there are a number of plaintiffs who are all alleging the same, or similar, accusations against a defendant, the Judicial Panel on Multidistrict Litigation (JPML) will determine if it is better to combine those lawsuits. When they determine it would be of better interest to streamline everything, they combine and centralize the lawsuits so that only one judge has to hear the facts, and then a decision is reached. Rather than have the same lawsuit going on all over the country, it is done in just one place. For the Xarelto MDL, Judge Fallon in New Orleans will oversee the case.
Setting up the MDL is just the first step though. There is much to come. For you, the plaintiff, you just need to supply your evidence and consult with your attorney. The hard work is then done between the attorneys, Judge Fallon, and the defendants, where they will get everything in order for the discovery process. The Judge will then proceed to bellwether trials, where jury reaction to the evidence is gauged. These trials will adequately represent all of the allegations, and can end up taking quite some time. For those who are not selected for the bellwether trial, it can seem as though no progress is being made. After the trials, it should be clear whether or not the defendant will be able to win the case or not, if they feel they will not then usually a settlement is negotiated. If they feel they are still not at fault, then the trials will proceed on an individual basis.
How to File Your Xarelto Lawsuit
Have you, or a loved one, used Xarelto and subsequently suffered from internal bleeding (commonly those who do suffer from gastrointestinal bleeding)? If so, then you can file a Xarelto lawsuit to collect compensation to cover medical expenses and other damages. Your first step is to contact a personal injury attorney from Arentz Law Group.
After you have scheduled your initial consultation, you should get all your paperwork together. From the hospital get your medical records that show when you started using the drug, and what dosage you were prescribed. These are important aspects to know just how long Xarelto has been causing problems in your body. In addition to the drug information, have records available that show when you were diagnosed with bleeding, and what corrective measures were taken.
An attorney from Arentz Law Group will be able to help you understand fully what you need and what you can expect from your Xarelto lawsuit.
How Long will my Xarelto Lawsuit Take?
The decision to consolidate Xarelto lawsuits into an MDL is only the first step in a long process. From here Judge Fallon will start to review the cases, and he will choose some that accurately represent all of the allegations against Bayer and Johnson & Johnson.
These cases will be heard before a jury, and their response can be gauged. These are not exactly the same as a regular trial, but rather if the jury sides in favor of the plaintiff on all of the cases, it is an accurate representation that the plaintiff will win the cases. The defendant(s), in this case Johnson & Johnson and Bayer, will then have the opportunity to settle the case. If they choose not to, then the cases will each go to individual trial.
Those cases are called bellwether trials, depending on how many of the cases are brought before the jury can determine how long your Xarelto lawsuit will take. Keep in mind that if your case is not picked as one of the bellwether trials, then it may seem as though no progress is being made. But rest assured, your dangerous drug attorney from Arentz Law is working hard to make sure you get the compensation that you deserve.
Contact Arentz Law Regarding your Xarelto Lawsuit
To get the process started, you simply need to call 1-800-305-6000, or fill out the contact form on this page. There is no need for you to suffer at the hands of a major pharmaceutical company. Instead taking part in a Xarelto lawsuit will let you stand up for your rights, and you can receive the compensation that you deserve.
