Pradaxa Can Be Very Dangerous!

Pradaxa at first seems like a good substitute for warfarin ( coumadin ). It does not require regular blood tests and it actually works better. But there's a HUGE problem in the event you develop a bleeding problem whether it be medical such as a stomach ulcer or traumatic such as a traumatic brain injury.

In either case it is important that your system be returned to normal clotting function as soon as possible.

If you are taking coumadin this is virtually no problem. They merely need to infuse you with an effective antidote, PCC, which will rapidly return your clotting function back to normal.

If you are taking Pradaxa, this can be a very big problem BECAUSE THERE IS NO ANTIDOTE FOR PRADAXA that an ER doctor can give you which will reverse the effects of Pradaxa. None. The only thing which can be done is to hook you up to a dialysis machine (normally used for people with kidney disease).

But even dialysis' effect is limited. It can effectively remove only 60% of the Pradaxa circulating in your system. Furthermore to attain that 60% level you must remain on the dialysis machine for from 3-4 HOURS.

For some minor to moderate bleeding, internal or external, dialysis may be helpful enough to help your body stem your bleeding, especially if it has been 10 or more hours since you had your last dose of Pradaxa. However for those with critical wounds who are bleeding acutely and profusely 60% will not likely do the job for you.

Furthermore, the 3-4 hours it takes for Pradaxa to be removed by dialysis may be 3-4 hours too long for your doctor to be able to keep you alive. This can be the case where your bleeding, whether because you fall, are in a car accident or if your gastrointestinal tract, puts on the course of fatal bleedout.

You don't have to lose anywhere near all your blood to die from blood loss. Nor is death the only possible consequence of having Pradaxa in your system when you need to get back your blood's natural ability to clot and stop or slow your bleeding. Blood brings oxygen to your organs. With less blood your heart will quickly start losing its ability to supply your organs with oxygen.

Most know that your brain can go without any oxygen for a maximum of 4-5 MINUTES before you will die. Fewer people know that once your heart starts supplying less blood and thus less oxygen to your brain, the longer it takes to restore normal blood flow there is an increasing likelihood that you will suffer severe brain damage. Brain damage can cause virtually any function of your body to cease functioning PERMANENTLY. You might not walk or be able to use your arms or speak. Naturally it can cause you great cognitive decline, not just in intelligence but also in energy, initiative, drive etc.

Blood loss causes swift damage both to the brain as well as to the kidney which can simply stop working altogether permanent, a sure eventual death sentence unless you can obtain a kidney transplant.

What may be the most likely major threat if you are older is a fall which causes your brain to start bleeding. Such bleeding simply will not stop without a return of your body to normal clotting function. 3-4 hours is way too long to stop brain damage, and unlike many other internal and external bleeds, surgery simple cannot stop bleeding. A bleeding brain quickly puts more liquid inside your cranium/skull. With no place to go, the pressure on your brain will go higher and higher, causing greater and greater permanent damage and soon death. The only option is emergency brain surgery, which will not stop the bleeding but simply give that excess fluid a place to go. The doctor may have to drill a hole in your skull or remove part of it to save your brain.

Remember, atrial fibrillation puts you at risk of having blot clots go to your brain and cause a stroke. But in an acute bleeding situation your risk of disability or death are far greater than your stroke risk at that moment. If you take warfarin / coumadin to "thin" your blood, you will be saved at the ER if you can be saved because coumadin has an antidote.

Pradaxa may be more convenient but it can much more easily interrupt emergency attempts to save your life after a broken hip or brain injury or a car accident or internal bleeding. That's because there IS NO ANTIDOTE FOR PRADAXA - there is an antidote to coumadin.

If you are on PRADAXA and have not yet discussed the above with your doctor it is absolutely urgent that you do so to allow you to make the proper judgment for yourself.

Another drug, Xarelto, performs similar functions and recent tests indicate that the antidote for coumadin works for Xarelto as well. If you have to choose only between Xarelto and Pradaxa, most definitely go with Xarelto, as protocol will soon be developed for Xarelto that could make it is reversible as coumadin is.

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REPORT

Thank you for your very informative post!

There are always risks associated with using any medication, some are more severe than others and anyone taking something should discuss all the risks and benefits with their doctor, before deciding on what treatment they should proceed with.

https:/­/­rxchat.com/­wiki/­Anticoagulant/­

Are there any questions or comments?

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In December of 2011, the FDA was alarmed enough about Pradaxa to commencing a formal evaluation of Pradaxa's inherent risks. This was an unusual step for the FDA to take with any drug, and a highly rare one for a medication which has been on the market for such a short time.
fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm

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I would think the fact there is no way of stopping a bleed out would be enought to keep them awake at night.

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Update: The results from an ongoing study comparing Pradaxa to warfarin found more adverse events with Pradaxa: publichealthwatchdog.com/study-highlights-more-problems-with-pradaxa/

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My mum (87)has been taking pradaxa since november 2011 after a few years on warfarin. Initially she noticed she was clearer in the head and she used to spot a little on warfarin and that wasn't happening. She developed rectal spotting.She was also suffering from bowel leaking. 2 visits to the bowel specialist who blamed pradaxa. One morning she had what i would describe as a period flow. the trip in the ambulance had me in a panic knowing there was no reversal. You don't think it will happen to you. Yes i had thought before re car accidents but once again you think it will not happen. the gp who is now sacked told me not to panic. when i ph cardiologist he said stop it now. yes the warfarin is a pain at times in the proverbial and the blood tests and changing dose a bit of a hassle but there is a reversal. so at the moment she is on nothing as her bowel settles.if she goes back on the warfarin there is a finger pricking machine apparently, although expensive, it might be the way to go for her. As for pradaxa- sorry no way.

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I agree, Pradaxa can be incredibly dangerous, specificlly due to a lack of antidote unlike coumadin. I found a lot of info on this link, hope this helps someone! gacovinolake.com/index.php?option=com_content&view=article&id=1971:severe-internal-bleeding-caused-by-pradaxa&catid=50:blog&Itemid=193

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My mother-in-law was changed to Pradaxa in Oct. 2011. In Nov 2011 she was rushed to the hospital for unexplained kidney failure. The kidneys started functioning again but no one could tell us why it happened. In Dec, she began hemoraging for no reason and was hospitalized with uncontrollable bleeding. Doctors had no idea why. I did an Internet search on Pradaxa as I knew this was the only thing that had been changed in her lifestyle. I was horrified to find these side affects listed and her Dr. Had no idea. We immediately took her off Pradaxa and after 3 weeks in the hospital and numerous transfusions, the Dr finally admitted that it sounded like it was probably the Pradaxa as there was no other medical reason. Since then her health has gone down hill fast and she has beef admitted 7 more times and is back in the hospital as I write this. Fluid keeps building on the outside of her lungs, she has shortness of breath and has a hard time remembering things. The Dr can find no medical reason or this except that it could be from kidney desease, which once more goes back to pradaxa. I cannot stress enough to anyone considering this drug that it is extremely dangerous. I feel very strong that my Mother-in-law will eventually become a fatality of this drug. It has already destroyed her quality of life.

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As a student in law school, I hope everyone has attempted to receive legal help! I am doing research on Pradaxa internal bleeding cases as we speak and am coming to find that this is not as uncommon as people think. The FDA alone has been receiving plenty of complaints from citizens. I am curious who else has had internal bleeding problems after taking Pradaxa? I have warned all of my family members against it..

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Simply wow- as a physician I must say I am astounded, and quite alarmed, by the amount of misinformation in this forum. Strongly recommend anyone who reads this speak with their physician first before making a decision, and not to solely use the information posted here.

As an example, remember that everything in life, including medicine, is a trade off between risks and benefits. Yes, pradaxa or any other blood thinner has risks of bleeding. But they also reduce the risk of bleeding. The issue of having an "antidote" is really just a technicality. When you look at the trials where they compared the newer blood thinners with the older one (warfarin), there were (in general) less major bleeds with the newer drugs (ie: the ones without an antidote). Furthermore, the risk of dying on the new drugs from a bleed was not any higher (and in some cases even lower). This suggests that having an antidote and bleeding on warfarin doesn't mean you're going to do any better, and on an intuitive level, this makes sense.

For example, if you are in a massive car accident, and tear open your abdominal aorta, it really doesn't matter if you are on coumadin or pradaxa. An antidote won't change anything. You will either die, or need urgent vascular surgery. Either way, the fact that you have an "antidote" available is irrelevant.

For a less extreme situation, if you have a bleeding stomach ulcer, yes you can get reversed if you are on coumadin. However, again, the studies show that even if you are on a newer drug, have a major bleed, your risk of dying is not any higher. Again, this makes sense intuitively - for a bleed, doctors can go in and find the source with a camera and inject it/burn it so it stops, or just wait transfuse you with blood until it settles down (if it's minor), or just watch and wait. Remember the effect of the newer drugs lasts a lot shorter (about 12-18hrs) compared to warfarin, so by that time, the drug has been completely eliminated from your body.

Finally, please remember- yes you can have internal bleeding with these drugs. But you have to be careful how you interpret it. These drugs do not CAUSE bleeding; however, if you have a bleed (ie: say you had an ulcer no one knew about), it will bleed longer because you are on the drug, that's true. But again, statistically speaking, you are much more likely to have a stroke because you are not taking a protective drug, than have a bleed and die because you are on the drug. Don't forget - always weigh the risks and the benefits. As a final example, I could say I don't want to leave my house because people die in car crashes or accidents. However, how am I going to eat? get groceries? go to work and make a living? socialize? Every day, and likely multiple times a day, you make a decision (conscious or unconscious) wherein you weigh the benefits (being able to go out of the house and do things) with the risks (getting hit by a car on the street, etc.).

Hope this helps. To be fair, I think we physicians are part of the problem with forums like these. Clearly we don't explain things well enough to patients, forcing them to resort to things like this. Personally, I do and try and spend as much time as it takes for my patients to have a clear understanding. The stuff described above is pretty much how I explain things to every patient I end up putting on these drugs.

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Not sure how old this conversation is, but my grandmother has been put on Pradaxa for a little while and her health has decreased immensely since being on it. Drs at unnamed hospital don't know what is wrong, but they've cut back her dosage. She woke up one day talking like she had a stroke, and her speech was fine the night before. Drs say she didn't have a stroke. Her speech is getting much worse.And MRI and cardiogram have been taken, among other tests I can't remember names for, and it is still a mystery. She had to be rushed to the ER twice in the last month to be defibrillated. She has experienced an overall decrease in her health since taking Pradaxa, and yet she can't not be on it. I'm not sure what she was taking to treat her afib condition, but she's never experienced problems associated with her afib until Pradaxa was introduced to her this year. I'm no medical apprentice, but I can't help but partially blame the medication. This is one of the most highest-risk prescriptions out there, and I wonder if never being put on Pradaxa would have been a bad thing. Do the pros really outweigh the cons? Once you start taking it, you can't stop, and now I feel like my grandmother is stuck in a health crunch she will never get out of because of this medication.

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Anybody have any comments on Pradaxa vs Xarelto

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There has been an "antidote" for Pradaxa (but not for the other NOACs) since 2015. Below is an abstract from a Project on Government Oversight (POGO) website:

"The FDA said it granted the Pradaxa antidote “accelerated approval.” That designation allows the agency to vet drugs based on reduced standards of evidence. In a June editorial in The New England Journal of Medicine (paywall), Kenneth A. Bauer, a professor at Harvard Medical School, wrote that test results were convincing that the antidote immediately neutralized Pradaxa.

The approval of the antidote, known by the brand name Praxbind and the generic name idarucizumab, makes Pradaxa the first in its class of new generation oral anticoagulants to have a reversal agent."

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After taking Pradaxa for the last week I've started having extreme pains in the middle of my back between my shoulder blades...and pains off and on in my stomach. Could Pradaxa be the cause?

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a 2029 report stated: "Idarucizumab (Praxbind) is a humanized antibody fragment, that reversibly and with high affinityties up dabigatran (Pradaxa). Anticoagulation reversal is achieved immediately, and with no procoagulant effect. It is administered intravenously and clearance is renal. The main clinical application of idarucizumab is to antagonize bleeding related to dabigatran, especially if it occurs at critical sites, such as nervous system (central or peripheral), intraocular, pericardial, retroperitoneal or pulmonary. Other indications are: i) dabigatran-induced anticoagulation reversal in the need for emergency surgery or procedures at high risk of bleeding; and ii) second-line treatment in bleedings that persist despite local hemostasis procedures."

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Re: LaurelLee (# 6)

There is an antidote to Pradaxa: Idarucizumab (Praxbind) is a humanized antibody fragment, that reversibly and with high affinityties up dabigatran (Pradaxa). Anticoagulation reversal is achieved immediately, and with no procoagulant effect. It is administered intravenously and clearance is renal. The main clinical application of idarucizumab is to antagonize bleeding related to dabigatran, especially if it occurs at critical sites, such as nervous system (central or peripheral), intraocular, pericardial, retroperitoneal or pulmonary. Other indications are: i) dabigatran-induced anticoagulation reversal in the need for emergency surgery or procedures at high risk of bleeding; and ii) second-line treatment in bleedings that persist despite local hemostasis procedures.

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Re: dsng (# 9)

But there is an antidote to Pradaxa. It has been available for many years Idarucizumab (Praxbind) is a humanized antibody fragment, that reversibly and with high affinityties up dabigatran (Pradaxa). Anticoagulation reversal is achieved immediately, and with no procoagulant effect. It is administered intravenously and clearance is renal. The main clinical application of idarucizumab is to antagonize bleeding related to dabigatran, especially if it occurs at critical sites, such as nervous system (central or peripheral), intraocular, pericardial, retroperitoneal or pulmonary. Other indications are: i) dabigatran-induced anticoagulation reversal in the need for emergency surgery or procedures at high risk of bleeding; and ii) second-line treatment in bleedings that persist despite local hemostasis procedures.

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