What is Xarelto?
Xarelto, a blood thinner is used by many Americans. In this article, we will read about Xarelto, how it affects the human body, side effects of Xarelto, mistakes that can be made with it, how to fix those mistakes and the consequences of not fixing them. We discussed it with many experienced doctors and today we will read a conversation which should clear most of your doubts about Xarelto and especially the side effects of Xarelto.
Dr. Dawkins, a clinical pharmacist, who specializes in drug interactions and the effects of those drugs on the human body describes all these things very well.
Dr. Dawkins, what does the Xarelto to do in the human body?
Well, Xarelto is a relatively new anticoagulant medication. What I mean by that is it’s a blood thinning medication. It was introduced in the United States in June of 2011. When it first came out on the market, it was indicated for the prevention of blood clots in the forms of deep vein thrombosis and pulmonary embolisms.
In those individuals undergoing knee and hip replacement therapy or surgery. Since that time the indications for the drugs have been expanded to include things like stroke prevention treatment of deep vein thrombosis and pulmonary embolism.
It directly inhibits an essential protein in the body called ‘factor Xa’ and that factor Xa in turn when it’s depleted, it affects the production of thrombin and ultimately the fibrin that produces a blood clot.
What types of surgeries would require you to need Xarelto to stop bleeding?
Well, what we would want to do is to stop bleeding. It’s to prevent a clot. These surgeries include hip replacements, we would see shoulder surgery or any other kind of surgery where the surgeon would want a short-term therapy or potentially even long-term therapy, where you are unable to form a blood clot or make it very difficult to.
How in the world did Xarelto get approved by the FDA?
Well, that’s a good question, and the way it got approved was it went through a process of performing this clinical study and the essential clinical study is called the rocket AF study. In the study, the manufacturers of Xarelto attempted to establish that Xarelto was just as effective in preventing strokes and blood clots as coumadin again that that’s basically called a comparison study and the study was designed really from its inception to create this impression that Xarelto was either non-inferior to Coumadin or that it was slightly better.
The problem with the study is that the rocket AF study really didn’t give the coumadin side of it a fair shake. Those on that arm of the study weren’t adequately controlled. I mean some of them were within that therapeutic range we talked about for only fifty-five percent of the time on average.
While in prior studies most people, who are monitored carefully on coumadin, were within that ideal therapeutic range for upwards of seventy percent of the time. Amazingly even with that advantage in the rocket AF study, Xarelto still performed no better at preventing strokes or blood clots then that old standby coumadin.
Most of the time, the pharmaceutical manufacturer does not provide the dangers of drugs to the doctors. So, you have good doctors out there in your area prescribing this drug because it’s been represented to be kind of a cure-all wonder drug, better than these others and the doctors themselves don’t know that it’s a problem until it’s too late.
Well, that’s right that’s one of the significant dangers with these drugs because you know you’ve got this medication that is sold as having an advantage over coumadin because it’s convenient. The problem is that the convenience comes at a severe cost.
Doctors aren’t told, and the patients certainly aren’t told, even in many cases, they’re not told that until too late. One of the number-one dangers associated with this drug and I think this is something that really bears mentioning is the fact that unlike Coumadin, Xarelto has no anticoagulation reversal antidote.
That’s a lot of big words. What it means is that when a person taking Coumadin has a fall, has an injury suffers a bleed. Undoubtedly, that bleeding will continue, but it can be stopped merely with a vitamin K antidote. It’s not true for Xarelto. There is no antidote. There is no right way to stop the bleed, and it becomes challenging to stop bleeding.
Can mistakes be made with the use of Xarelto in the body?
Yes, we can see that from many vantage points. We can see it initiating from the physician himself. The medication requires special dosing. So, in the cases are also if you’ve had a surgery, you might be started on one dose which maybe a 15-milligram tablet twice a day and then you’ll take that for a few weeks and then they’ll switch you to a different prescription. We call that titration schedule. That is one place that we see that.
We also would want to know whether or not that medication is dosed directly in terms of either a liver function or kidney function in some cases that can affect the dose that is given?
Titration is basically what different drugs on different days or different numbers of pills on different days. You might take one tablet twice a day for three weeks, and that might be a 15-milligram dose, and in that case, you would be taking a total of 30 per day and then after that 21-day period you would then switch to 120-milligram dose. After that, when you get that medication, you have to make sure you’re getting both prescriptions because you’ll have to continue that therapy.
It could be a different dosage on different days, or it could be a different number of pills on different days, both?
A doctor could write the wrong prescription, the pharmacy makes an error with Xarelto. As with many medications, the medications have to be input into the system. That’s one place that it could be missed, the drug could be misinterpreted.
Meaning they think it says Xarelto, but it really says a different medication. Then if they get all that correct, the person actually filling the drug could also make a mistake and put the wrong tablet in there. A lot of the pills looks the same color.
Okay, well if the doctor or the pharmacy makes an error and you’re the patient. What sort of consequences from Xarelto mistake could a patient expect?
Well, the Xarelto is an anticoagulant and so what you would expect in that case is, to see some bleeding. Just because the body doesn’t have the ability to clot as well as it did before.
They’re all together targeting a specific function in the pending clotting cascade, so it makes it a little bit more difficult to stop it. While if you had drugs such as warfarin, it could be treated a little differently so in the case of Xarelto it makes it a little bit more difficult to stop the bleeding.
Xarelto mistakes are more difficult to correct?
So what sort of bleeding are we talking about?
You’re looking at internal bleeding you’re looking at nose glaze, you’re looking at large bruising those can manifest themselves. If they’re internal as nauseousness, you might see blood in the stool. Those are kind of warning signs for the patient.
Let’s say you’re a patient and say you’re getting a headache. You didn’t usually have it or nosebleed or blood in your stool, or you know, it’s just somethings off at what point should they ignore it and at what point should they report it to the doctor?
If you are experiencing symptoms of nauseousness, nosebleeds and you’ve just had surgery those are things that are going to you know require you to get in and get seen very quickly. What you’ll want to do is bring in a list of medications to the office, if most likely they’re going to the ER or some type of urgent care. Bring that list and tell them if you are on a titration schedule. That will help determine their course of action based on where you are in that therapy. So, you’ll want to do that and then get seen as soon as possible.
What if you’re one of those patients and you ignore it, I mean how bad can things get with this
You would expect internal bleeding to be able to manifest itself into whether you know blood in the stool, nosebleeds, like we said those were some of the consequences eventually untreated you could potentially pass away.
Do you, in fact, see deaths from Xarelto?
We have seen deaths in the past from Xarelto. That is why we suggest all the patient going to the doctors and get seen if they are having any of these symptoms.
There are some cases in which lawsuits have been filed. Xarelto lawsuit is again a different topic and we will discuss that, for sure, in our upcoming blogs. Stay tuned.