Xarelto

Why I'm still hesitating taking Xarelto instead of Pradaxa: Side effect: Thrombosis (blood clots)

Of the more than 1,800 Xarelto-related reports in FAERS, the outcomes experienced by patients varied. Initial or prolonged hospitalization occurred in 891 cases. Death was the outcome in 183 cases. 180 cases were deemed life-threatening, and 62 resulted in disability. 7 required intervention to prevent permanent damage.

The other Xarelto side effects included in FAERS are (in order of most common to least common):

Thrombosis (blood clots)
Decreased hemoglobin (a protein in the red blood cells that transports oxygen)
Cerebrovascular accident (any type of physical event that leads to a stroke)
Hematoma (a semisolid blood mass)
Peripheral edema (swelling of the lower limbs)
Dyspnea (difficulty breathing)

[www.xareltolawsuitlawyer.com]

Stephen

Stephen, I wouldn't take much stock in a lawyer site. They have an axe to grind and all the new anticoagulants have gotten chop jobs from them.

Jim

Stephen, I am sensitive to medications and so far, 2 months of xeralto, so good. Dennis.

Me, too.

______________
Lone paroxysmal vagal atrial fibrillation. Age 62, female, no risk factors. Autonomic instability since severe Paxil withdrawal in 2004, including extreme sensitivity to neuro-active drugs, supplements, foods. Monthly tachycardia started 1/11, happened only at night, during sleep, or when waking, bouts of 5-15 hours. Changed to afib about a year ago, same pattern. Frequency increased over last 6 months, apparently with sensitivity to more triggers. Ablation 6/27/13 by Steven Hao.

Stephen - if you search back in the various posts by Shannon where he discusses the downside of the new anticoagulants, you'll note that he is warning that the major focus of concern is about lack of clotting and the fact there is no antidote yet. Even with even with minor accidents there have been deaths. If it's a traffic accident, there is little that can be done, apparently. In one post he talks about a man who cut his ear in a traffic accident and they couldn't stop the bleeding and he died after even with receiving something like 60 units of blood. Apparently, there is a very expensive antidote that costs something like $10,000 ( I think he said) and he commented that how many people would actually receive that ...if the ER even had it available. You should do the search - I'm just going from memory...

But I did save a comment Shannon wrote in one post a while back so I could send to a friend considering using one of the new anticoags:


......" BTW, my niece who is chief attending physician in one of the largest Level 1 Trauma Centers in Texas in Houston is just finishing a larg report comparing Coumadin and Pradaxa/Xeralto in the trauma setting.

The latest data shows that for people on either Coumadin/Aspirin/Plavix coming to the ER due to a bonefide 'trauma' with significant bleeding approximately 30% die as a result of excess bleeding.

That sounds like a lot, but consider 70% of those same degree of trauma patients who are on Pradaxa wind up dying!!!! Mostly from bleeding out or related breakdown!! That really IS a lot!

So if you are taking Pradaxa/Xeralto and don't plan to live in an isolated padded cell, then based on these preliminary marketing data the Drug reps have been hawking to all the eager EPs and Cardios...these new figures might give them some real pause for thought!>! Or at least I would hop so until they get a far bettter antidote." end quote.

Jackie

Thank you Jackie and for others comments too

Jackie, quote scary but fact!

[www.pharmacytimes.com]

[www.medpagetoday.com]

Stephen

I really worried about the tendency to throw up coffee grounds. Such dire adverse effects can happen on any anticoagulant. Xarelto does not seem to be particularly dangerous.

______________
Lone paroxysmal vagal atrial fibrillation. Age 62, female, no risk factors. Autonomic instability since severe Paxil withdrawal in 2004, including extreme sensitivity to neuro-active drugs, supplements, foods. Monthly tachycardia started 1/11, happened only at night, during sleep, or when waking, bouts of 5-15 hours. Changed to afib about a year ago, same pattern. Frequency increased over last 6 months, apparently with sensitivity to more triggers. Ablation 6/27/13 by Steven Hao.

I will not take anything asides from Warfarin until they have a solid, fast acting, reliable, non-toxic ANTIDOTE for it!!!!!!!!!!!!!!!!!!!!!!!!!

My father was on Warfarin when he took a bad bad fall this year. Had he been on any of the "thinners" asides from Warfarin, for which there are fast-acting antidotes, he would have died. I repeat...... he would have died.

It is as simple as that. You want to play Russian Roulette? Go right ahead. Not for me. I strongly suggest that one thinks very carefully about taking the blood thinners that do not have an immediate antidote, as Warfarin does. I would much rather waste an hour getting blood drawn and tested once a month than chance a bleed from which there is NO RECOVERY.

Besides, in addition to having my INR checked monthly, I also get them to check a bunch of other stuff, life Potassium, Creatinine, etc. Worth the hour it takes.

PLEASE PLEASE PLEASE take some time to investigate and make an educated decision before taking these potential killer drugs. Please. I will stick to Warfarin until the others have antidotes and less side effects. Jeez, the TV commercials are 75% CYA babble for these other drugs.

Murray

Murray L

--------------------------------------------------------------------------
Tikosyn uptake Dec 2011 500ug b.i.d. NSR since!
Herein lies opinion, not professional advice, which all are well advised to seek.

Thanks, Murray,

RE: PLEASE PLEASE PLEASE take some time to investigate and make an educated decision before taking these potential killer drugs. I am!

FROM: [www.cbgnetwork.org]

"The approval process for Xarelto was difficult from the very beginning due to the many side effects and unclarified long-term effects. In India, at least four people taking part in the Xarelto trials have died. In each case, BAYER paid the surviving dependents a mere USD 5,250 as compensation. In the United States, therefore, Xarelto will be marketed with a warning that patients should not stop taking the drug without consulting a physician, as there is otherwise an increased risk of strokes occurring."

Forgot to attach:

Old news --- but of interest:

[www.citizen.org]

from:

[www.cbgnetwork.org]

My unopened bottle of 90 Xeralto pills (and indeed expensive) does not expire unitl July 2014. I will discuss my rejection with my cardio next appointment.

Thanks again,

Stephen

One thing about the Internet, you can find evidence that will scare your pants off about anything.

[www.drjohnm.org]

Quote

Over the past year, I have yet to see a major adverse event with rivaroxaban, and this experience includes cardioversion and AF ablation. I asked around and my colleagues echo the same sentiment. Although early, and I could be wrong, I don’t think this is fluky. Consider that in the Einstein-PE trial, rivaroxaban, albeit at a higher dose, proved to be an effective strategy to treat pulmonary embolus (blood clot in the lung.) This is significant because PE is a disease that requires potent anticoagulation. That rivaroxaban worked so well speaks to its anticoagulant effects.

[www.medpagetoday.com]

Quote

FDA Reviewer Slams Xarelto for Stroke Prevention in Afib

Published: Sep 6, 2011

....
Despite the overwhelmingly negative tone of the FDA review, there were no new safety issues uncovered, the reviewers said.

In fact, rivaroxaban-treated patients experienced numerically fewer critical organ bleeds, intracranial hemorrhages, hemorrhagic strokes, and fatal bleeds compared with patients treated with warfarin.

....

I talked to a very busy cardiologist as well as my EP about Xarelto risks. Both assured me they had no qualms about it.

Personally, I'm very glad I don't have to contend with the complexities of warfarin.

______________
Lone paroxysmal vagal atrial fibrillation. Age 62, female, no risk factors. Autonomic instability since severe Paxil withdrawal in 2004, including extreme sensitivity to neuro-active drugs, supplements, foods. Monthly tachycardia started 1/11, happened only at night, during sleep, or when waking, bouts of 5-15 hours. Changed to afib about a year ago, same pattern. Frequency increased over last 6 months, apparently with sensitivity to more triggers. Ablation 6/27/13 by Steven Hao.



Edited 4 time(s). Last edit at 08/09/2013 08:09PM by Iatrogenia.

I too chose not to let Warfarin run my life. I've read all the reports about Pradaxa but I am still on it. I think it has a lot to do with your own blood clotting, which I believe is different for a lot of people. I just recently cut myself on the arm and by holding a kleenex on it for a couple of minutes, it stopped bleeding. I know it might be different with a car accident, etc., but with Warfarin I also had to pay each time I went in. There are many things we do in life that could be considered Russian roulette, including driving across town (on Pradaxa or not!) ; I guess this is one for me!

Oh boy. I literally JUST started taking Xarelto tonight! I am scheduled for an ablation on Sept. 5th, and am even a few days behind in starting it. This post isn't giving me a "warm fuzzy' at all....

So what does someone do if they are Xarelto and they get wounded in some way? Are you saying there is no way to stop it? I would hope that Dr. Natale would not recommend something that was dangerous for us to take.

I don't like playing Russian Roulette either..but aren't we doing that whether we take anticoagulants or not?

Will be glad when this is all behind me....geez! ~ Barb

I've been on Xarelto for close to a year with absolutely no issues. Being on the other side of a TIA looking in was no fun as I was speechless for 10 mins and that's the bottom line. Paralysis possibly for life or a blood thinner?
I wouldn't lump Pradaxa in with Xarelto, that's not what Shannon said, not enough data yet but it does seem safer. As a matter of fact Dr N prefers to use Xarelto pre and post ablation and feels it's safe. We talked about the fact of its fast acting ramp up within 2 hours being attractive if one goes into AFIB and not having to wait weeks to get stable on warfarin. My cardio who has hundreds of patients on Xeralto has not seen the issues as he did with Pradaxa. Yes Pradaxa has issues with GI bleeding and renal clearance issues and I wouldn't take that as it's too dangerous.For me no way on Warfarin.
We should really refrain from scaring people and keep the eye on the ball as a stroke is forever.



Edited 2 time(s). Last edit at 08/10/2013 10:28AM by McHale.

StephenL Wrote:
-------------------------------------------------------
> Forgot to attach:
>
> Old news --- but of interest:
>
> [www.citizen.org]
>
> from:
>
> [www.cbgnetwork.org]
>
> My unopened bottle of 90 Xeralto pills (and indeed
> expensive) does not expire unitl July 2014. I
> will discuss my rejection with my cardio next
> appointment.
>
> Thanks again,
>
> Stephen

This is old news and the concerns have not panned out on Xarelto.
And 2 years later Xarelto is being used by one of the top EP's in the world pre and post ablation with no problems.



Edited 1 time(s). Last edit at 08/10/2013 10:41AM by McHale.

From what I have read, there is no antidote for Xarelto, which is the concern about Pradaxa. In what way is it better than Pradaxa other than taking it once a day instead of twice?

[blogs.nature.com]

Shannon once again sums it up nicely on this post

[www.afibbers.org]

There is abundant cause for concern with the new anticoagulant drugs and the lack of a readily available and also proven effective antidote. A decision to use them, should be based on facts such as what Shannon has brought up and will eventually be published in a major journal.

However and unfortunately, those facts are not as widely-known as they should be. If you check safety issues for Xalerto or Pradaxa, you see that there is a risk for uncontrolled bleeding, but no warnings about the dire consequences of an auto accident, a fall with head trauma or other major accidents that could cause bleeding from an open or internal wound….or a discussion about the antidote and reliable availability for reversal.

Meanwhile, consider that many doctors may be unaware of the lack of the antidote…or the fact that interim antidote called prothrombin complex concentrate (PCC) may be useful for some but may not be readily on hand in local ER’s or on the Emergency ‘wagons.’ Or… doesn’t work for all of the new anticoags.

Patients need to realistically address the risk factors involved and make a decision based on the best possible info at that point in time. We are extremely fortunate to be forewarned by Shannon’s inside knowledge coming right from that large Trauma Center. …and as he has pointed out in various posts, not all physicians are aware of the severe downside and the risks involved. Typically the drug reps educate and sell the use of the latest drugs. Very often, they fail to mention or don’t fully address factors that put the drug in a less than favorable light. It happens all the time... just think back to the many various drug recalls after 2 – 3 years where the public was used as guinea pigs and the results weren’t safe.

Last year when I had the Lyme and AF trouble and it appeared that after 4 days, I might have to be electro-cardioverted, but was not on a blood thinner, the EP who helped out suggested I go on one of the new anticoags …and as he put it… “in case you need the ECV, it’s convenient, you don’t need to worry about coming in for checking the INR and if the flutter doesn’t convert, we can get you in the lab for ECV in a couple weeks.”

My response was… (thanks to Shannon’s previous alerts)… “Well, Dr. X… what about the fact that there is no antidote? Would you feel comfortable taking that drug yourself?”

His response was, “ Well, I can write you a prescription for warfarin and put in an order for you to visit the Coumadin clinic to become established.” … and he did just that. He never answered either of my questions but that spoke volumes to me. I also asked him for a prescription for Vitamin K and received it.

Ultimately and obviously, the decision to use or not is personal, but it should be an informed decision not based on feelings, hunches, or other non-factual information.

My wish is for all afibbers to remain safe.

Jackie

Again it's half the story so lets talk about compliance. My cardiologist who has 5 offices and has a huge patient history after 25 years sees much less people stroking out now.
How many more strokes have been prevented because more patients are willing to use these new drugs.
This means that managed care may be able to vastly reduce the cost of paying for stroke care for the patients currently in rebellion against warfarin who then suffer a stroke. These are patients — up to half of those who have been prescribed the drug — who refuse to take warfarin or take it irregularly for their AF condition and then are hit with a stroke. Warfarin will stand alongside the new drugs, but these other drugs are more patient friendly. A hoped-for outcome is that patients will be more likely to take their medicine and thus prevent strokes. And that means big savings in managed care expenses.
So it's all about preventing stroke and that my friends is more important then the relatively small bleeding risk and death in ERs.



Edited 1 time(s). Last edit at 08/10/2013 03:11PM by McHale.

Warfarin adverse effects <[www.drugs.com];

Quote

....
5. WARNINGS AND PRECAUTIONS
Hemorrhage

Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur within the first month. Risk factors for bleeding include high intensity of anticoagulation (INR > 4), age greater than or equal to 65, history of highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, anemia, malignancy, trauma, renal impairment, certain genetic factors [see Clinical Pharmacology (12.5)], certain concomitant drugs [see Drug Interactions (7)], and long duration of Warfarin therapy.
....

6. ADVERSE REACTIONS

The following serious adverse reactions to Warfarin sodium are discussed in greater detail in other sections of the labeling:

Hemorrhage [see Boxed Warning, Warnings and Precautions (5.1), and Overdosage (10)]
Necrosis of skin and other tissues [see Warnings and Precautions (5.2)]
Systemic atheroemboli and cholesterol microemboli [see Warnings and Precautions (5.3)]
Other adverse reactions to Warfarin sodium include:
Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions)
Vascular disorders: vasculitis
Hepatobiliary disorders: hepatitis elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of Warfarin sodium and ticlopidine.
Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating
Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia
Respiratory disorders: tracheal or tracheobronchial calcification
General disorders: chills

....

As with so much in medicine, you pick your poison. Personally, after all I've been through, the very small risk of bleeding to death from an accident while I'm on Xarelto seems a relatively benign way to go.

______________
Lone paroxysmal vagal atrial fibrillation. Age 62, female, no risk factors. Autonomic instability since severe Paxil withdrawal in 2004, including extreme sensitivity to neuro-active drugs, supplements, foods. Monthly tachycardia started 1/11, happened only at night, during sleep, or when waking, bouts of 5-15 hours. Changed to afib about a year ago, same pattern. Frequency increased over last 6 months, apparently with sensitivity to more triggers. Ablation 6/27/13 by Steven Hao.

I went from Warafin to Pradaxa to Xeralto.

I could not get my INR stable on Warafin, so during my ablation and hospitalization they used Heparin to bridge.

Following my first ablation at the urging of Pr. Jais in Bordeaux I went on Pradaxa. I immediately had severe diareha until I switched to Xeralto about a week later.

The Bordeaux doctors seem to think the benefits of these new drugs outweigh the risks.

One of the troubles with Warafin is the need to limit vitamin K. If you are trying to live on a high fibre healthy diet, this is difficult.

I have had a few minor scrapes and the bleeding did not stop immediately, but fairly quickly.

I don't like any of these drugs, and intend to get off of them as soon as possible. I just completed a holter test which I hope was OK and will be talking to my doc this week about testing my blood thickness before I jump to eliminating the drugs.

Ron

If I found I needed to stay on an anticoagulant long term I will consider going back to Warafin

Dr. Natale has been touted here as one of the very best. He told me to go on Xarelto one month before my ablation, which I just started yesterday. If I am going to trust him with my heart, I have to hope that I can also trust his judgement as to what to take to make this a safe and successful experience.

If you read the inserts that come with almost every prescription drug, you wouldn't take any of them. The very fact that it's a prescription drug means that it has potentially troublesome side effects and cautions. For those taking Flecainde (like I do), the possible side effects are daunting. I could develop a fatal arrythmia according to the insert. Yet this drug improved the quality of my life significantly. I have had none of the side effects, other than a little more fatigue than I would like. The slight trade off is well worth it to me.

Am I taking a risk? Yes. But so am I by not treating Afib and letting it continue unchecked. McHale has already experienced a TIA - many others have suffered strokes. I sure dont' want to do that.

It's clearly a personal decision. I've decided to trust Dr. Natale, be aware of possible side effects but also not obsess about them, and do what I need to do to get to where I need to be. And yes, be a little more careful too, (not a bad idea anyway)

~ Barb

"You pick your poison"... so true.

My dad was, as I said, on Warfarin. His fall was so severe that he was not only bleeding internally, but blood was coming out of his eye, nose, ear and he sure looked like he was not going to make it through the night. It was only by the Grace of the Almighty and the antidotes to Warfarin that he survived. What more can I say?

Here I am, on Warfarin, have been for 4 years, and my INR is relatively steady, excepting when I consume too many dark green veggies.... I tend to now maintain a steady intake of same rather than 'on and off'. And I note that when I poke myself and draw blood it does take a little longer to stop bleeding but nothing alarming.

I can't help but continue to wonder what I would do if I was on one of the new thinners and DID have an accident of significance.

As far as being more careful is concerned, we had a friend who passed away about a year ago. The most careful fellow you could ever imagine. I think they even used plastic cups on the patio. One day the dog jumped up while the were playing and he fell backwards and struck his neck on the brick surround to the garden. Presto, instant quadriplegic and a miracle that he survived the first night. He was airlifted by helicopter to the trauma center. He managed to survive two and a bit years before pneumonia took him from us all. So, my point is simply that you can be as cautious as possible and life throws you a curveball. Good night Charlie.

So, "select your poison" is probably appropriate but still, I'd like to think that a medication is being served up to me not because it is more convenient but because it is more effective.

I keep an open mind. One reaches a point where one MUST keep an open mind I suppose. Four years ago this month - my birthday is on Monday... August 12.... nobody would have wagered a nickel that I would be around to celebrate it after two weeks on total life support and months in the hospital as a result of the after effects of Influenza A/H1N1 (which is probably where all of this started in the first place).

Murray L

--------------------------------------------------------------------------
Tikosyn uptake Dec 2011 500ug b.i.d. NSR since!
Herein lies opinion, not professional advice, which all are well advised to seek.

I am also on Xarelto and about 7 weeks post ablation, I thought the reason why we are on a blood thinner post ablation is in case we go into AFIB the blood thinner would be there to protect us against a clot, but if Xarelto is so fast acting then why not wait and see if we go into Afib and then start the Xareltoat at that time. Just a thought.


KenH

Ken,
It surely also has to do with tissue damage and resultant scabbing from the procedure itself - during that healing process there is an increased likelihood of clot formation.

Tom,

Thanks, I wasn't aware of that. I am hoping I can get off of Xarelto sooner rather than later, I make furniture as a hobby and I am not going near the power equipment until I am off of this stuff. I am waiting for my blood test results from my hemotologist, my liver enzymes were slightly elevated from the Xarelto before the procedure and now I am curious to see if they stayed the same or increased, if they went up any more then back to Wafarin for me.

Ken

Ken - my EP told me to wait one to three months after the ablation, have a holter and if everything is ok to eliminate the drugs. He said "it would be too bad to stay on these drugs if there is not a reason".

I just had a 48 hour holter and in my doctors absence had a glance at the report at her reception and saw that I had 187 ectopics including 6 "runs" and no dangerous dysarythmias. I hope this means I am good to go.

I have never visited a hematologist, but am considering it. Can you tell me what your thoughts are about having your blood checked by one before elimianting the anticoagulants?
Ron

McHale, thank your for the blog post. I research from time to time whether "they" are coming up with an antidote for the new anticoagulants, but haven't seen one this recent. Hopefully it will be approved soon, although it seems to take longer in the U.S. It DOES remind me, however, that I should keep a note on myself at all times that I am on Pradaxa. I don't take any other medication for afib (was on Multaq, but it didn't seem to have ANY effect, so I decided why risk any of THOSE side effects for nothing!)

I will persevere with my supplements, changed diet (which I keep trying to improve), exercise, and pray that someday we will learn to preserve our perfectly made bodies without all of the financial and political input!

Louise

KenH, my EP is participating in a multi-center trial of your idea of using a Pradaxa as a PiP. The study is enrolling paroxysmal afib patients who have infrequent episodes and are normally not on blood thinners. They all have ILRs or pacemakers so the docs can monitor for episodes. When a participant reaches a certain afib duration threshold according to their monitor, they get a call with instructions to go on Pradaxa for a certain amount of time (I believe he said 5 days) then, as long as the afib converted and has not recurred, they go back to being off anticoagulants until the next episode.

Ron - Shannon has posted previously about the new sophisticated and very accurate lab testing for hyperviscosity through Meridian Valley Labs... if you can locate those posts.

It's definitely smart to learn about your viscosity markers... including ferritin, fibrinogen, HgA1C, HS CRP, Homocysteine and Lp (a) since they are all various markers signalling a tendency for thick, sticky blood which can cause adverse clotting problems... keeping in mind many factors including inflammation drive the stickiness.

Jackie

Cathy B,
I talked to Dr Natale about if I knew about Xarelto last year I could have used that as a PIP during my fatal labor day weekend when I suffered a TIA. He agreed that would have been they way to go since I couldn't do that with Wafarin. This would probably be the way to go forward when we decide I can stop Xarelto as long as I check my pulse before and after bed.
I also have the AliveCor heart monitor so I can double check. Wondering if he's also participating in the trials.?

Louise,
Glad they are getting close to some antidote, hopefully in the next 2 years.
Are you in permanent AFIB and did you also have a TIA if I recall?



Edited 1 time(s). Last edit at 08/11/2013 08:21PM by McHale.

Looking in database for my cardio who switched me to Johnson & Johnson's Xarelto :

[www.thehealthyhomeeconomist.com]

[projects.propublica.org]


Perhaps all drugs cost could be lowered if kicbacks not given.

Stephen

The Xarelto tablet comes in a precious little designer shape that I'm sure adds to the cost, as does the TV advertising and the whole full-court marketing press.

I hate the drug companies.

______________
Lone paroxysmal vagal atrial fibrillation. Age 62, female, no risk factors. Autonomic instability since severe Paxil withdrawal in 2004, including extreme sensitivity to neuro-active drugs, supplements, foods. Monthly tachycardia started 1/11, happened only at night, during sleep, or when waking, bouts of 5-15 hours. Changed to afib about a year ago, same pattern. Frequency increased over last 6 months, apparently with sensitivity to more triggers. Ablation 6/27/13 by Steven Hao.

Jackie - you mentioned inflammation...as I am now on Xarelto and nearing my ablation date (Sept. 5th), do you know if it's Ok to take Omega-3's along with the Xarelto? I believe it has blood thinning tendencies too, doesn't it? I would like to be on it for the protection against inflammation, but wasn't sure...

Barb

Ron B,

I had seen a Hematologist previously due to an elevated Hematocrit level so I only went back due to finding out that my liver enzymes were elevated from the Xarelto. I don't think I would have sought out a hematologist if I hadn't already been seeing one. He did tell me that liver enzymes increasing is not a normal event for people on Xeralto.

Jackie, in your post you mention the viscosity markers including ferritin, well the hematologist told me that my ferritin levels were a little elevated and I find out on tuesday if they are still up and if so he wants to send me to the NIH here in the DC area to get their opinion on it.

KenH