From Orleans, LA comes the news that the first trial against the medication, Xarelto, will be held in early 2017. Others are due to follow. There is a huge portfolio of xarelto claims against the maker, Jannssen Pharmaceuticals Inc., and Bayer, which are still pending. The number of cases is nearly 14,000.
The plaintiffs allege that Xarelto caused blood to thin so much that it caused serious complications to patients. As there was no antidote to the blood thinner’s power, it caused serious harm. The first plaintiff to have his trial states that he was prescribed the medication for atrial fibrillation or Afib in early 2014. One month later he was in the hospital with bleeding so severe he required many blood transfusions.
He claims the makers mislead the public about the medication’s safety. They also failed to indicate the dangers of the drug to the medical community or to the US Food and Drug Administration. They only referenced certain results from clinical trials to get the pill on the market. The issues of the medication were not disclosed.
Xarelto was compared with its rival medication, Warfarin is also known generically as Coumadin. This medication requires routine blood tests and dietary restrictions of the patients who take it. Xarelto came out as being a much easier medication to take with as much safety and effectiveness as Warfarin.
There were tests done on the two and allegations were made against the readings taken of patients by Inratio. It was believed the readings showed patients in a control group taking too much Warfarin thereby casting a better light on the Xarelto. The FDA feels that any variations in the readings done by Inratio were too slight to skew the results for Xarelto. Originally, Xarelto was approved for DVT or deep vein thrombosis.
Eventually, Xarelto was introduced to the market to be a better, easier way of managing Warfarin patients. It seemed to be too ineffective at reducing the risks of DVT or stroke from atrial fibrillation. It helped manage the levels of Warfarin used. Too much of the Warfarin itself risked hemorrhages, and bleeding.
In their xarelto claims, plaintiffs made note of the lack of an antidote available to combat the excess Xarelto bleeding. With Warfarin, patients are taken care of with a vitamin K infusion. The treatment does not work on Xarelto, leaving it to be a risky medication. Plaintiffs further claim that the makers of Xarelto were irresponsible for claiming that Xarelto required no monitoring. Because it did not have a reversing agent, the opposite became true.
Xarelto came on the market with big expectations. In the first year on the market, it brought in close to $600 million. By the end of 2013, it yielded $2 billion. The future of the drug remains to be seen as these xarelto claims lawsuits come to trial.
What makes Xarelto different than the other blood thinner medication is that it is actually a Xa inhibitor, meaning that it works to think out the blood by blocking thrombin. This is the chemical found in the blood that leads to a blood clot. Being able to block thrombin, Xarelto works to break down and then prevent any blood clot that can be a problem if you have gone through either knee replacement or hip surgery, are going through deep vein thrombosis or have been diagnosed as having atrial fibrillation.
The major side effect linked to Xarelto use is internal bleeding that is uncontrollable. Internal bleeding can be a lot more dangerous than external bleeds, as it is more difficult to identify. Since Xarelto will keep the blood from clotting, internal bleeding events can result in the need for hospitalization right away, or even death.
Along with severe internal bleeding, one serious risk that has been linked to the use of Xarelto is that it can lead to blood clotting if the person stops taking the drug before they are supposed to. This is something reported as happening whenever a patient is transitioning from Xarelto because there is no reversal agent, back to the drug Warfarin, which happens to have a reversal agent in it.
Back in 2013, the FDA put out a report that was focused on adverse medical events that are linked to the use of Xarelto. The report noted that about 2,100 of the people surveyed had reported adverse events concerning Xarelto. Out of that, 1,821 of the people cited Xarelto as being the main cause of the event.
The major four side effects to be reported in the study were:
– Deep Vein Thrombosis
– Pulmonary Embolism
– Gastrointestinal Bleeds
Some of the other adverse events that were included are cerebrovascular incidents, thrombosis, edema, dyspnea, and hematoma and hemoglobin deficiency. With 891 of the cases that were reported, hospitalization was necessary. Unfortunately, 183 of the cases resulted in the death of the patient.
A pulmonary embolism is something that happens when the blood flowing to the lungs gets blocked due to a blood clot. This is most commonly caused by a deep vein thrombosis, which is where a blood clot gets formed down in the veins of the legs or arms, then travels into the lungs where it forms a blockage. The symptoms of pulmonary embolism include severe chest pain, coughing up blood, and shortness of breath. The symptoms might only occur after serious damage is already done. A pulmonary embolism is difficult to diagnose, often leading to death.
This is internal bleeding in the abdominal area, which can be very serious. The abdominal region holds a lot of vital organs. In the event that there is an internal bleed, the blood can pool around such organs and then cut them off from the supply of blood that is freshly oxygenated. Whenever organs are cut off from oxygen for long, they will start to die. The signs of a gastrointestinal bleed can include coughing up blood or vomiting it up, resembling coffee grounds.
Internal bleeding in the brain has been always very dangerous. This can result in suffocation of the brain cells as they starve for oxygen. If they get cut off from oxygen for far too long, they can begin to die, leading to effects that are similar to a stroke. The signs that there is a brain bleed can include numbness in the arms, legs, or face, speech that is slurred, difficulty when moving or walking, harsh headaches, lack of coordination and impaired vision.
Many critics say that Xarelto is also far more dangerous than other available blood thinner medication because there is nothing that can be used as a reversal agent. If any patient that is taking Xarelto goes through internal bleeding, you do not have a drug that will counteract it to stop the bleeding.
The makers of the Xarelto drug have filed a lawsuit for patent infringement cases. Janssen Pharmaceuticals and Bayer A.G. have filed a lawsuit against the company Brecenridge Pharmaceutical, alleging that the company has tried to infringe on the Xarelto patent. Bayer is the maker of the anticoagulant in most countries; also Janssen makes it in the U.S.
Breckenridge has filed an Abbreviated New Drug Application with the FDA, which is for a generic version of the anticoagulant. Both Bayer and Janssen believe that as soon as the application is approved, Breckenridge will release their generic version of the drug. The existing patent for Xarelto, however, will not expire until the end of the year 2020.
The accusations of patent infringement cases were based on reasons, since Boehringer Ingelheim, the makers of Pradaxa, sued Brekenridge when they filed an ANDA for a generic version of Pradaxa two years ago. There are concerns that the company is too eager to enter into the anticoagulant market, and that it is throwing patent rights out of the window because of its enthusiasm.
Xarelto and Pradaxa are both big moneymakers, but there are a lot of problems with the drugs. There are lawsuits plaguing both of the medications, and concerns that Pradaxa could have some serious side-effects. Patients who experience uncontrolled bleeding, however, say that Boehringer Ingelheim did not give them sufficient warning of the risks. The company was ordered to pay out $650 million as settlements for lawsuits because of these side effects.
Xarelto is the subject of similar patent infringement cases, with Bayer and Janssen likely facing significant financial penalties because of the 6,000 lawsuits against it – which may be worse because there is no antidote, and the bleeding events can be life-threatening.
The generic version of the drug could escape some of the legal liabilities, since the makers of generics are not required to update their warnings when brand-name drugs change their warnings. They have the choice about whether or not they need to update their packaging to reflect changes.
The generic makers have limited liability because of the restrictions on them. For consumers, this means that they do not have so many rights to hold the generic makers responsible for their drugs. Janssen and Bayer, however, are not eager to hand over the rights to the drugs.
The FDA reports that there were more than 10,600 reports relating to adverse events after taking Xarelto in 2015, and that included 1,121 deaths and 4,508 injuries severe enough to require emergency treatment or hospitalisation. Xarelto is one of the poorest ranked drugs in terms of requiring hospitalization.
Xarelto is used in a lot of different scenarios, and the number of patent infringement cases is growing and growing. There will be a trial in March 2017, and it is expected that by then there could be more than 10,000 outstanding Xarelto lawsuits. Plaintiffs say that the makers misrepresented the drug. The initial approval was controversial. The manufacturers will, naturally, want to avoid a scenario of a third party getting approval for a less-risky generic version.
Xarelo is a new Novel Oral Anticoagulant category (NOAC) blood-thinner medication manufactured by Johnson & Johnson and Bayer AG. It is used for treating several different conditions, including deep vein thrombosis, pulmonary embolism and atrial fibrillation. However, Xarelto is considered to be a high-risk medication and ruled responsible for serious injuries like liver damage symptoms and the deaths of several patients. Hundreds of lawsuits have been filed against the manufacturers of the drug as a result of so many individuals suffering uncontrollable internal bleeding to the point that even after being hospitalized doctors still had no way of stopping it. Unlike other similar drugs like Warfarin, there is no known antidote for reversing the effects of Xarelto, so once life-threatening bleeding takes place; the patient is at risk of death or severe injuries.
However, there are also several other potentially very serious or fatal side effects for Xarelto that are still under post-marketing investigation currently since the drug was introduced in 2008 to the worldwide market. Risk of liver damage is one of the more alarming adverse reactions that is associated with the drug Xarelto. Liver damage symptoms caused by Xarelto have been investigated for being a potential risk for individuals taking Xarelto medication. There have also been several Xarelto-induced liver injury cases that have been reported. These include several cases of acute liver failure. The results from three big international pharmacovigilance databases were recently analyzed. The analysis revealed that Xarelto was suspected to be a cause in a large number of hepatic adverse cases.
In addition to gastrointestinal bleeding and internal hemorrhage, liver damage symptoms are the most reported Xarelto side effect. It can be discovered in blood tests by elevated enzymes AST and ALT. The 4 Record study results showed that of the 6,183 patients that were treated with rivaroxaban, 2.33% had increased liver enzyme (transaminase) levels that were over 3 times higher than ULN (upper limit of normal). There were two other cases where patient showed liver damage symptoms after being treated with Xarelto which were published recently in the Journal of American Medical Association, which further confirms this drug’s alarming potential hepatotoxicity.
Another thing that should be noted is that more than two-thirds of the drug, which is administered orally, is eliminated via urine or bile following hepatic metabolism. If liver function has been comprised, the blood levels of the drug may potentially increase due to the liver being unable to eliminate a sufficient quantity of Xarelto out of the body. However, this medication’s main selling points were the fact that blood monitoring was not required and its purported safety. These points were advertised widely over the internet and television.
Without any blood monitoring, it results in patient not being aware if the effects from the drug have increased to the level of growing potentially dangerous due to an increased risk for bleeding accidents. Therefore, this requires that an appropriate adjustment to the dosage be made.
Since being treated with Xarelto can potentially be associated with symptomatic and severe liver damage symptoms and consequently bleeding risk, the physician and patient both need to be fully informed about this potentially significant danger. The drug label should include a warning about the potential symptomatic liver damage; otherwise patients who suffer liver injury as a Xarelto side effect have the right to file a lawsuit in reference to misleading information being provided by the manufacturers.
Have you taken Xarelto and now you are wondering if you have suffered any side effects from it? Maybe you are wondering what the side effects of Xarelto are. If you are curious about the side effects of xarelto, then continue to read the rest of this article, as some of the side effects will be discussed below.
There are quite a few common side effects associated with Xarelto, and this includes pain in the back, bleeding gums, as well as blood in your stool. The pain in your back could vary in pain, and so can the amount of blood in your stool. Asides from those three side effects, other common ones include bowel or bladder dysfunction, as well as tingling feelings or the feeling of pins and needles. You might also experience some itching or burning.
Those who cough off blood or have a hard time breathing or swallowing may be doing so because of using Xarelto. The drug can also cause you to have a headache and you might feel dizzy, as this is another side effect associated with the drug. Another common side effect that some users may experience is weakness in one or both of their legs.
Nosebleeds, prolonged bleeding from cuts and numbness are other common side effects associated with Xarelto. Not only that, but other common ones include stools that are tarry and are red or black. If your urine is red or dark brown, then it may be because you are using Xarelto, and if you are a woman, then you may experience an increased menstrual flow.
There are even more common side effects that the drug has. One of the most serious and common ones is throwing up blood. Sometimes you might vomit material that resembles coffee grounds, and you might experience paralysis.
Xarelto can cause less common side effects, which includes fainting. Not everyone will experience this side effect, but some people may. Feeling pain in your arms or legs, as well as wound secretion are other less common side effects of xarelto.
Asides from the common and less common side effects, there are a few rare ones that some users may encounter. One of the most rarest ones is burning while urinating. As for how much it will burn, that depends, but generally speaking, a burning sensation may be felt by some users of Xarelto
Another rare one is having a very hard time urinating. You may feel like you have to urinate, but you may find it difficult to do. Asides from being difficult, you might even find it painful to urinate.
If you experience those side effects, and you are taking Xarelto, then you should contact your doctor. The side effects may be the result of using the drug. Even if they are not, it is still a good idea to have a doctor look at you.
There are some side effects of xarelto which are not really familiar, therefore it is not really proven that some unknown incidents are a result of using Xarelto. With that said, it is possible that some other side effects associated with Xarelto are pain in the stomach region, as well as swelling and your vision may become blurred or your skin could blister up or peel. Very dark urine is another potential side effect, but unproven one.
There are two more side effects that could potentially be linked to Xarelto and this includes blisters. If you take the drug and notice that blisters have appeared, then this may very well be because of Xarelto. Muscle spasms may also be experienced by Xarelto users, and if you do experience such symptoms, then you might want to consider getting medical attention because it may or may not be the results of using Xarelto.
As you can see, there are a lot of different side effects of Xarelto. If you suspect that you have suffered from any of the above side effects, then you should visit your doctor as soon as possible. They will be able to examine you, speak with you and determine whether or not Xarelto resulted in side effects.