Below are some of our videos explaining the potential dangers of Xarelto, and especially the connection to uncontrollable bleeding. To learn more about the types of injuries that have been linked to this medication, and the legal claims that have been filed, click Xarelto.
Lawsuits Claims Xarelto Causes Incurable Bleeding
Papantonio: Ned McWilliams, Xarelto the killer drug of the week. When does it stop? This is almost black humor what we see coming out of the FDA nowadays.
McWilliams: It's just the same story over and over again, unfortunately. Yeah, Xarelto it's the latest one in this whole line of drugs that it is doing the same thing. Literally, hundreds if not thousands of people believing the death because of the drug.
Papantonio: Okay, lay it out for us. What is the drug, why do people take it, why don't doctors know that they shouldn't give it to their patients?
McWilliams: It's called Xarelto. It's part of this whole new class of drugs that came out. They are all meant to replace Warfarin and it's for elderly folks who have atrial fibrillation which is just a heart arrhythmia. The thing is that that's a very large population. We're talking about millions of Americans with atrial fibrillation who they're trying to push these drugs on through all the direct consumer advertising that I'm sure everyone's seen. What I think people don't know is that the people that have actually investigated the safety of this drug like the 2 primary doctors at the FDA they actually voted against this drug getting approved. They said it should not get approved. They said it doesn't look safe. It doesn't look effective and they gave very good specific reasons and the bureaucrats just vetoed them. Trumped them. They guys over-
Papantonio: Why? We've seen so many times with the bureaucrats actually end up working for the industry. In other words, the bureaucrats work in their day 1. Day 2 the industry comes and says "Hey, we'd like to give you a raise of $300,000. Oh, by the way, what about helping us with this drug." It's bribery. It's nothing short of bribery.
McWilliams: I think it's a bribery. I think it's a combination of the revolving door you see between industry and the regulators but also the thing that I think you called it the captive agency. We have these agency where they just do not have the power or they are disenamoured by the power of these drug companies. Here we're talking about Bayer and Johnson and Johnson. Just behemoths. 2 huge drug multimillion dollar drug companies.
Papantonio: On Xarelto, we're talking about Xarelto here. In Xarelto, you have this huge companies coming in and basically pushing the FDA around holding out these gifts if you would for the FDA types saying you know "I know you're only making $120,000 come with us and make $300,000 and oh, by the way, can you help us with getting approval on this drug."
McWilliams: That's part of it and another part that I think a lot of people don't understand is the lack of power that the FDA has. They don't have much power and I actually found a document the other day when I was researching this topic where someone within the FDA wrote and they said look and it's the core allegation, in this case, is that a simple a blood test could improve patient safety. The FDA says look the data appears to show that a blood test could improve patient safety but for whatever reasons the drug companies aren't interested in pursuing this avenue and so the FDA acknowledges that they just do not have the power to require the companies to do what the FDA believes is right. Which is just ludicrous.
Papantonio: What are the important points about this Xarelto story that really just causes you to get angry when you know how many people this is killing?
McWilliams: For the start of the matter, we don't need it. We have a drug that is tried true tested called Warfarin that doctors have been using for 50 years and it's cheap. It's 300 bucks a year. These new guys on the market they are selling it to our grandparents and they're telling it's cheap and quick and you don't have to go to the doctor anymore and but they're charging them $3000 a year for this drug.
Papantonio: Their argument is you don't have to monitor the blood amount.
McWilliams: Exactly you don't have to do the regular blood test which is true but the fact of the matter is if you did like simple 1-time blood test or a yearly blood test you could greatly improve patient safety and they know this. There is a recent huge expose in the British medical journal just in the last couple of weeks where they said that the same thing is true for another 1 of the drugs in the class and so there is no-
Papantonio: Wait wait when you say drugs in the class what do you mean? There is a class of drugs that you're talking about here. It's not just Xarelto. It's other ones too.
McWilliams: It's Xarelto and Eliquis and there is a new one that's coming down the pike. I don't know the trade name of that yet. I think it's called Endoxipan is its generic name.
Papantonio: Okay but we're talking about Xarelto here and the FDA is doing what with Xarelto? Are they doing anything to stop this?
McWilliams: Absolutely nothing and they're going to get into it. They're going to dive in. Their market share is going up. People have been paying more attention to it. I know that there is a lot more attention to the whole class of drugs in general. I think eventually we're going to get to a place and a point in time where all these drugs require at least a 1-time blood test just to make sure you're getting the right dose and that's going to happen. I think some other concerning things about Xarelto is again if you dive into the data is that the way you measure how well this drug performs is you do a head to head clinical trial. Which is what they did here with Xarelto.
They compared it to Warfarin but the thing about Warfarin is that it requires you have to constantly change the dose and you can measure how well you do that and they did it very poorly. They managed Warfarin very very poorly and yet Xarelto still had more strokes and more bleeds than Warfarin. Even in poorly controlled Warfarin and that's another one of the reasons why the people of the FDA voted against approving the drug. The actual scientists, the doctors but the bureaucrats again overruled them.
Papantonio: Obviously, if somebody is on Xarelto right now the doctor most of the time is not going to know a lot of these issues we're talking about. That sounds odd but the doctor really won't even know that maybe the clinicals aren't quite right or why the clinicals are actually showing or maybe they shouldn't be on this drug at all because there is something called direct to consumer marketing explaining that would you?
McWilliams: Yeah, the thing is there is market research that shows that 9 out of 10 doctors will prescribe a drug to a patient if that patient asks for it by name. That's why in the United States drug companies pharmaceutical companies spend tens if not hundreds of millions of dollars on direct to consumer advertising. Which is really just it's crazy that why would you be advertising to patients when the patients don't have the power, the ability to actually write these prescriptions. It's the doctor's choice, it's the doctors decision yet they know the influence they have through these patients and the doctors just don't have the time to do all the research and they ultimately just have to trust the FDA and their peers and the drug companies that they're giving them safe medicine.
Papantonio: What a mistake that is. What a terrible mistake that is. Ned McWilliams than for joining me.
McWilliams: Thanks, Pap.
Xarelto Lawsuits Are Climbing Due to Severe Bleeding Issues
Mike Papantonio: Drug companies are no longer driven by a desire to heal. They're solely driven by profit, and that greed is helping to put some very dangerous drugs on the market. Joining me now to talk about some of the most dangerous drugs that are in the hands of consumers right now is attorney Ned McWilliams. Ned McWilliams, another drug out there killing Americans. Just the same story, FDA dropping the ball. FDA not doing their job, and now we have another product that has potentially killed thousands of Americans, Xarelto. Tell us about about it.
Ned McWilliams: Yeah, it's another one of these drugs that the FDA is quick to approve for atrial fibrillation that's causing ... Not the potential to cause thousands of deaths, but it is causing and has caused thousands of deaths. It's another one of these drugs that's a race to the market to get a drug that doesn't require monitoring of the blood, which is what everyone thinks they need as an alternative to Warfarin. Really what they're not telling folks is that if they did monitor the blood, they could be saving lots of these lives as opposed to causing all of these unnecessarily lost lives.
Mike Papantonio: Ned, explain what kind of drug this is.
Ned McWilliams: It's called the new or novel oral anticoagulants. There's Eliquis is in the same class, Xarelto, and there's even a new fourth one that's coming down the pike. They're all the same in that they're supposed to be as good or better than Warfarin, but you don't have to go to your doctor on a regular basis to have your blood tested. They are touting this as an advantage, as a benefit over Warfarin. Therefore, as a reason to charge so much more for the drug. These drugs are like $3,000 a year versus $400 a year for Warfarin.
Mike Papantonio: Ned, you've actually seen the working documents, you've seen some comparatives with Warfarin. For example, Warfarin has been on the market 60 years or so. We know that its morbidity rate is way low compared to Xarelto. You've actually seen the numbers of comparatives on Warfarin, that is a proven drug, and Xarelto, that's Johnny–come–lately on the market, just a cash cow that this company's trying to develop. Tell me about it.
Ned McWilliams: There's a patient safety network out there called The Institute for Safe Medication Practice, and they track this sort of thing. It's called adverse event reporting system. What they do is they basically keep track to see how many people, how many events are reported of patients suffering serious or fatal bleeds on Xarelto or Warfarin, or any drug for that matter. What they've found is that Xarelto's now outpacing, out-tracking all other drugs in the class. It's the number-one serious adverse event reported drug in the country.
Mike Papantonio: Ned, how did they get away with this for so long? What I mean is, when you saw the comparatives, you get Xarelto saying, "Look, we're the new drug to solve atrial fib. We're going to solve that problem." It was almost as if Warfarin was old news, no longer relevant, and then they come out with comparatives to look like it's a safer drug. How did they do that and have the FDA not catch those kinds of things?
Ned McWilliams: It's inexcusable. I don't know what the explanation is. It's sitting right there. The fact that we're able to see it so easily, the FDA should've been able to see it as easily. The fact of the matter is, their clinical trial did not establish efficacy for this drug. What it is, it's called a head-to-head trial. What you do is you compare the number of bleeds and strokes with the new drug with the number of bleeds and strokes that you saw with the time-tested Warfarin. What they found was the numbers were about the same.
The thing about Warfarin is that it's all about how you manage it. Warfarin, it's not as simple as you just take the medicine and forget it. You have to manage the patient. You have to make sure they're not taking interfering foods or other drugs. There's a way to measure it. It's called "timely therapeutic range." The timely therapeutic range for the Warfarin patients in the Xarelto clinical trial was abysmal. It was terrible. It was in the 50% range. Any drug is going to look good compared to that.
Mike Papantonio: Okay. You have Xarelto come onto the market. You have the Madison Avenue type saying, "Gee, this is the best drug because A, you don't have to monitor. If you don't have to monitor, there's going to be better patient cooperation. If you don't have to monitor, patients are going to be more willing to use the drug." Which is nonsense. If you-
Ned McWilliams: I don't know if you've seen the commercial recently. The way they're really preying on people now is they're saying, "Oh, now you can finally go to Europe for the summer. You don't have to be stuck in the museums." That's the Xarelto commercial I saw just this weekend.
Mike Papantonio: Okay, the idea is we're saying all the drug companies basically take the decision-making away from the doctor. What they're doing with direct-to-consumer marketing is they're brainwashing the patient to then go to the doctor and ask for these medicines. In other words, it's a complete reversal. You got somebody out there that's on Warfarin. They're doing just fine, they've taken it for 10 or 12 years, no problem with atrial fib, they don't mind monitoring. Then the next day, they hear a Xarelto commercial, and they say, "Doc, I want to take Xarelto." You have the company actually selling the patient so the patient will go sell the doctor. Aren't you seeing that a lot, not just in Xarelto?
Ned McWilliams: I was going to say the same thing. Not just with Xarelto. We saw this with other products we've worked on. These drug companies know that if a patient goes in and asks for a drug by name that 9 out of 10 doctors will prescribe it to that patient. Even if it's off-label, which is frightening. It shows you how doctors just want to appease their patients. It's easier to write a prescription rather than to provide them with a 20-minute consult on why this drug may not be the best for them.
Mike Papantonio: Isn't this why they don't allow direct-to-consumer marketing in so many countries? Isn't this part of the problem? They know the statistics. They know that when somebody is fearful of their health that they want to take every bit of advice they can. Sometimes contrary to the doctor's advice, because look, they sit in front of the television set, they see a 30-second spot. The spot says, "This is the solution. Go tell your doctor you want this, and you're going to be well." That shouldn't be allowed in this country, just like it's not allowed in so many other countries.
Ned McWilliams: It's not just so many countries. I believe the United States and New Zealand are the only countries in the world that allow direct-to-consumer advertising. I know just from speaking with professionals around the world, they think it's just such an odd system we have here. That they're able to market these drugs to individual patients who really don't have the right or the power to decide whether or not they take them. It's up to the doctor. It's a doctor who has the right to prescription. Clearly that shows you the power of the patient. Otherwise, why would they spend hundreds of millions of dollars advertising this?
Mike Papantonio: One reason that they're trying to kick the doctor out of the decision-making we saw in a case you and I handled last year on Yaz. Yaz was a birth control. We settled that case nationally for all the women who had had strokes, who'd died, just horrendous kinds of things. We saw in that case that they had done research, and they understand if they can scare the hell out of the patient, then that patient will do whatever it takes to demand from the doctor that they get that medication. Plus, we also saw the second part of that. The second part was the company wasn't even telling the truth to the doctor about how dangerous the product was.
Ned McWilliams: Right. It's disease-mongering. What we saw with Yaz is they invent a disease. They call it "disease state awareness." Really they're inventing a disease. Erectile dysfunction wasn't a real disease until they had a medicine to sell you to treat it. The same thing is true with pre-menstrual dysphoric disorder, which is what they did with Yaz. Similar to what they're doing right now with atrial fibrillation drugs. Lots of these patients that are on Xarelto, Eliquis, they would be just fine and actually much safer if they just took Aspirin. They don't even need to be on Warfarin. They could just be on Aspirin. They've convinced this larger group of people that they need treatment and they need to go to their doctor right away, otherwise, like you said, they put the fear of God in them. They make them more afraid of dying.
Mike Papantonio: It is fear-mongering and it is the worst. The Xarelto product is exhibit A. I would advise people that they need to go back to the doctor and ask about Xarelto again. The numbers I'm seeing are staggering, and they're scary. Ned McWilliams, thank you for joining me.
Xarelto was a new drug approved in 2011 for the prevention of stroke in patients with atrial fibrillation. It is part of a new class of drugs called new oral anti-coagulants. Xarelto claims to provide an improvement upon the standard therapy for atrial fibrillation for the last 50 years, a drug called Warfarin, also known as Coumadin.
At first blush, Xarelto appears to be equally effective as Warfarin at preventing strokes. However, because it is a blood thinner, it also greatly increases your risk of experiencing a major bleeding event, but there is hope, and that is it's possible to significantly reduce your risk of suffering a major bleed while on Xarelto. It's a simple blood test. Warfarain patients have undergone this blood test for decades in an effort to reduce the risk of a major bleeding event.
Unlike Warfarin, the makers of Xarelto, the drug companies of Bayer and Johnson & Johnson, have claimed in their advertisements and other promotional materials that Xarelto patients don't need to have their blood tested. They claimed this is an advantage over Warfarin therapy and that not needing a blood test justifies them charging Xarelto patients almost 10 times more than Warfarin patients.
This claim is simply not true. Recent publications indicate that if patients on these new drugs including Xarelto were to simply have their blood tested and then have their dose adjusted based on the results of that blood test, that their risk of a major bleed could be reduced by as much as 20 to 40 percent. This information has not been shared with doctors or patients. If you or a loved one have experienced this serious or fatal bleeding event while on Xarelto, you need to contact an experienced drug litigation attorney immediately to discuss and preserve your legal rights.
At Levin Papantonio, we are the national leaders in drug litigation. We are invited to speak at all the major conferences. We work with internationally-renowned medical scientists. We take the key depositions in these cases and we will take these cases to trial if necessary. Please call me immediately to discuss your case.