I was just wondering for all of you who are on Warfarin (I myself am on aspirin) if you have heard anything about the drug Pradaxa being used for Hughes Syndrome? I first found out about this drug in relation to my father's heart problems. I believe it is a blood thinner like Warfarin but it is safer in that you don't need to keep testing your INR(?). I expect it may well have its own side effects like all drugs. I think it has been approved for use in the US but my father's doctor told him that the NHS are still waiting for it to be approved here by NICE.

39 Replies

  • dear kay- be careful ,here in the states [ pradaxa ] has been approved since 2010 - adds are appearing on t.v. -260 people have died since it was started being used here ! the goverment as we speak is calling for another study now. i was debaiting with my rheaumy , the use of it , i descided against it- i believe it needs more study- as i dont think ,my self its for everybody. but then again there are alot of meds that arent for everyone. not trying to scare anyone just look closely at this one.--------------------------------------- jet

  • Hi Kay,

    In the UK it is still on the trial here i think its used for surgery but not approved for anything else.

    It does have a number of side effect but again no clear info yet well not on the UK side anyway


  • Jet- can you find out more or direct me where to get more info on that? I hadnt heard about the deaths and I would like to find out as much as I can.

    Pretty Please? ya ya?

  • I am happy with warfarin it's doing a brilliant job keeping me alive and I am a great believer in the saying If it aint broke don't try and fix it x

  • Thanks Jet for your reply and for the information on Pradaxa. I'll pass that on to my father. I always assume that it's mostly money that makes NICE slow in approving medicines but it sounds as though they might be right in the case of Pradaxa. Fortunately, I'm only on aspirin but may have to change to Plavix because aspirin is playing havoc with my stomach. I've also read that Plavix has its own list of bad side effects too!

  • Hi KJay

    yes I appear to be having problems with Plavix. London Bridge Dr in May, 2010, said Plavix, not warfarin yet- have had cardiovascular bleeds etc over years. Living in north Qld it took a year before I started taking it, with eye specialist here who researched APS, and rheumy in Sydney. A flight incident August last year led to suspected DVT- then since unexplained severe bruising, marking on legs, arms, muscles and over left kidney, with swelling. My GP knows nothing about this, will have to see General physician and possibly a visiting vascular physician- who probably doesn't know APS, My research led from knowledge that some patients cannot use Plavix, must take tests. I am allergic to so many meds, including penicillin, sulfas, etc- have stomach ulcers, been on Plaquenil since 200. As others suggest, will have to email/write to dr at London Bridge Hospital where I went. Have photographed the bruising.

  • Hi Mary

    I really feel for you with all your problems on Plavix. I hope you manage to get some answers from London Bridge Hospital. I'm not sure what to do as I have been on aspirin since 2008 and will probably have to come off it onto Plavix as aspirin has probably been causing internal bleeding (I still have to go for a colonoscopy to verify this). I know what you mean about being allergic to meds. I haven't had the number of bad reactions you have had, fortunately, but I have had to come off Plaquenil. I was on the lowest dose taking it every other day and yet it still affected the macular in my right eye. I was told to stop Plaquenil immediately when I experienced a circular grey blob in my vision which I only really noticed when reading type. I didn't know it was being caused by the Plaquenil. After two months off Plaquenil the blob disappeared and my eye is OK. The opthalmologist told me I was very lucky as often the sight can continue to degenerate in spite of being of the medication! I was told by my rheumy that in 5 years of research there had never been a case of macular degeneration on Plaquenil and it surprised everybody as the dose was so low. Not much comfort to me to be the unlucky person that is affected! It has made me very cautious about meds. I wonder how many other APS sufferers have drug sensitivity or could it be another autoimmune condition as I also have Sjogrens?

  • I have multiple drug allergies, including (unfortunately for me as a Hughes patient,) heprin and lovanox. Sigh. Also the "canes" such as novacaine, so I must get a local compounding pharmacy to mix up some preservative-free lidocaine for dental work. (Lidocaine does not numb jaws as well as novacaine.) The allergist's theory is that I am actually allergic to a stabalizer or preservative. I wish I knew which one because then I could avoid certain drug company products -- whichever company uses the offending preservative. But nope. I don't get to know. (I'd jeopardize the drug company's proprietary secrets, don't ya know.) So, I just hope that if/when I am in that accident and carted off to the ER that everyone has the benadryl and epipens at the ready.

  • gina u should always carry an up to date epipen with you... i do.... i thought the drug companies here in the USA have to divulge ingredients to the FHA..can you contact them??

  • The allergist told me that were in England determining exactly what I was allergic to would be relatively simple iinvolving a letter from the NIH allergists college to the manufacturers. And yes, a close reading of the Merck manual will reveal likely provocateurs, but without the actual stuff in a vial to do a reaction test on me, we will only be guessing. And here in the US getting hands on the actual, isolated preservative hardly ever happens -- and when it does it comes at the far end of a lot of waiting, documentation and legal fees. So, I carry that epi pen and warn docs to have the epinepherin and benadryl ready whenever anything invasive is contemplated.

    I recently reacted to either the dulcolax or the miralax used to prep for a colonoscopy. Also, I had a cup of tea a good month after the CDC told us here in W.Va. that it was safe to drink the water and -- I broke out in hives. (Note: my town, St. Albans was not effected as we have stubbornly held on to our own municiple water plant. But all the surrounding towns were.)

    So, my allery issues continue -- but so far nothing that benadryl can't master.

    Some doctors imply that I"m manufaacturing my drug reactions out of some buried neuroosis. If so, as I asked on this site once before, would someone please tell me how I'm doing this so I can patent the procedure and make a fortune from students wanting to get out of tests and workers wanting to take some more time off? I'd be a millionaire! or a billionaire!

  • "reactions out of some buried neurosis"...the story of my life since i was 23 yrs old...still get "that" look from some doctors..

  • hi kjay, i was taking plaquinal and became allergic to it...i broke out in a full body rash and some minor swelling...i do have eye problems now and then..clouding and impaired vision but they clear seems to be when my count goes high ..when it drops back down things clear up..

  • And about the pradaxa: it was here in the States that (I think) someone posted in the "Antiphosphowhat?" newsletter that Pradaxa is a most dangerous drug. And the reason you don't have to have those blood tests? -- pradaxa's effect on blood viscosity can not be accurately measured by PT/INR tests. So, if the test can't provide reliable information, then . . you shouldn't have the test! Again, someone correct me if I am wrong. I hope I am. Warfarin works well for me, but its nice to know one has some back-up arrows in the quiver for those 'just in case' scenarios. But from what I've heard, pradaxa does not sound like a "user friendly" arrow.

  • Re: Pradaxa and INR tests -- blood tests are not necessary, which is one of the big benefits of Pradaxa since the "clotting cascade" is blocked by another mechanism. Also what you eat, consistent Vitamin K, doesn't matter either. I sure wish this was the magic bullet, but I'll stick with the tried and true warfarin for as long as I can. They are discovering too many problems, and we know about being skeptical about drugs that are rushed to market with biased tests. Anyway, my father went on it for the only "approved" therapy here in the US, for atrial fib, (irregular heartbeat) and we did not have good results. Too much gas, diarrhea, and unexplained leg pains. He has continued to have the leg pains since being taken off the drug last year, but the gas went away within a week or so.

  • I'm with the if it ain't broke don't fix it school for Warfarin.

    When you read patient responses about Plaquenil, including blindness and other awful side effects, and then read about the deaths and other dreadful complications from Pradaxa, the rational response is to stay with what works - even if it requires blood tests and even if there are some ups and downs. at least it doesn't blind or kill you.

  • I guess all meds are 'controlled' poisons but I guess they're the lesser of two evils although sometimes I have to wonder!

  • When I first went on warfarin, (in the 80s for DVTs attributed to a high platelet -- I was then taken off when the platelets returned to normal and Thats when the migraines and mini -strokes started. ) Anyway. My OB/GYN then told me that warfarin was a "perfect drug." He defined perfect as "we know what it does and thats the only thing it does. It interrupts Vitamin K metabolization. It thins the blood. And thats it. All side effects are natural consequences of thinning the blood, so they're not side effects they're actually the down side of what we're after. So, though its called 'killer coumadin,' I think its a safe drug because we know so much about it and it only does what we want it to."

  • also it is a drug that can be reversed if needed to to prevent a deadly bleed out

  • The new oral anticoagulants have not been trialled and there will not be given to APS patients.

    We are involved in the RAPS - Rivaroxiban APS proposed trial but are still trying to get funding for a research nurse.

  • Coumadin (Brand names include Warfarin, Jantoven, and Uniwarfin) has been on the United States market since about 1954. This well-known anticoagulant continues to be commonly prescribed to patients who are at risk of blood clots which can lead to serious consequences such as stroke and death. While Coumadin has been time-tested and proves itself to be quite effective, and relatively safe (“safe” based on a risks and benefits analysis which considers the serious consequences of not anticoagulating patients at high risk of clotting). To maintain safety while taking Coumadin, a

    patient must allow blood levels to be tested about every three months

    (to make sure there is not too much or too little in a patient’s system) and avoid foods which contain

    Vitamin K (such as many leafy green vegetables) which can render coumadin ineffective. Failure to take coumadin exactly as prescribed and to monitor coumadin levels can lead to uncontrolled bleeding which if not treated emergently can cause a patient to bleed to death. Fortunately, there are several antidotes to coumadin toxicity – all of which are commonly available to healthcare professionals. Antidotes include injectable Vitamin K, plasma (fresh frozen or cryosupermatant plasma), prothrombin complex concentrates, and recombinant factor VIIa.

    One of the big “selling” points for Pradaxa as opposed to coumadin is that the patient taking Pradaxa does not have to submit himself or herself to regular blood draws and dietary restrictions. What promoters of Pradaxa conveniently do not tell physicians and patients is that there is no commonly available antidote for a Pradaxa overdose. Thus, should a patient’s Pradaxa levels reach a toxic level, he or she has a good chance of bleeding to death while physicians watch helplessly. Pradaxa levels are effected by advanced age, renal (kidney) function, extremes in body weight, and drug-drug interactions (aspirin, ibuprofen, nonsteroidal antiinflammatory drugs, and many other commonly used drugs). According to the National Center for Biotechnology Information, “In early 2013, there is still no routine coagulation test suitable for monitoring these patients; specific tests are only available in specialized laboratories. In early 2013 there is no antidote for dabigatran, rivaroxaban or apixaban, nor any specific treatment with proven efficacy for severe bleeding linked to these drugs. Recommendations on the management of bleeding in this setting are based mainly on pharmacological parameters and on scarce experimen-Haemodialysis reduces the plasma concentration of dabigatran, while rivaroxaban and apixaban cannot be eliminated by dialysis.”

    In the last few years, several thousand patients, who have suffered serious injuries including death, have sued Boehringer Ingelheim Pharmaceuticals, Inc., the manufacturer of Pradaxa for failing to warn patients and their physicians about the serious adverse events that may result from taking Pradaxa. Many of these suits also allege that Boehringer promoted Pradaxa as being safer than coumadin.

    If your physician has prescribed Pradaxa for you, you should immediately discuss whether there are safer alternative drugs for you. After weighing the risks and benefits, you and your physician can determine what drug is best for you. If you have taken Pradaxa, and have suffered uncontrollable bleeding, you should consider consulting with an an attorney.

  • absolutely...thanks for posting this..:)

  • You're welcome. Should "they" get a readily available and safe antidote, then maybe Pradaxa would be a welcome change to the warfarin blood level checks.

    - Paul

  • Yep. For me its not "killer coumadin," its actually my best friend. I do eat green and leafy but I try to eat the same amount every day. And my INR has been stable for years.

  • Warfarin does have its downsides... regular blood draws, dietary restrictions, and drug interactions, for example, but many physicians are very comfortable with it as it's been extensively studied and is familiar.

    - Paul

  • Indeed, my understanding of this new drug is that there is no known antidote, and it is one size fits all.

    I'll stick with warfarin thanks, as I have for over 40 years.

  • Forty years? That is tried and true... though, at one time warfarin was a new drug... it's just that these new drugs have to be fully understood before falling for the Big Pharm ad campaigns.

    - Paul

  • You may wish to view the transcripts from last year's Patient's Day - Hughes Syndrome Foundation Patient's Day 2013. For sale for a nominal sum through Hughes Syndrome Foundation charity website. Professor Hunt gives a very good talk on the new development with certain drugs, weighing up the pros and the cons. MaryF

  • I will... thanks.

    - Paul

  • Paul I need you to remove the link advertising your website please, it goes against all the rules on our forum, I hope you understand. MaryF

  • Thank you, MaryF

  • No problem... feel free to edit, delete, change, as you see fit to comply with guidelines... and for the record... not one word of what I post here or on any site should ever be taken as medical advice... education? hopefully... but never ever advice.

    - Paul

  • Paul, do you have APS? This is a Forum for people who have the condition. Its not for people to come on and advertise themselves!

  • I do not, and apologize. Please delete all my posts. I am sorry to have intruded.

    - Paul

  • my rhumey says an absolute no to it because if you get a serious bleed thay can't stop it like coumadin/ careful...

  • Not yet, anyway... "they" are working on a readily available and safe antidote... but right now? It does not exist.

    - Paul

  • Thank you Doctor Paul for you good information.

    I live in Sweden and here we stick to warfarin. I have had all the antibodies in high levels for 12 years and warfarin has been my "saver". As I also have Lupus Anticoagulant it can be difficult to control but in Sweden (around the Stockholm aria at least) everybody on warfarin can have a Coagucheque machine for free. Without it I would have problems with lab veintest twice a week.

    Kerstin in Stockholm

  • dr. Paul may i ask where in USA are you located??

  • California.

    - Paul

  • Many thanks for the information Paul.

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