By Jeff Balke
By Ben DuBose
By Ben DuBose
By Sean Pendergast
By Sean Pendergast
By Calvin TerBeek
By Jeff Balke
By Jeff Balke
Available in a single, 150-milligram pill (in the U.S.), Pradaxa doesn't have warfarin's myriad drug interactions or dietary restrictions, nor does it require monitoring.
However, there's one difference that works in warfarin's favor: Pradaxa has no reversal agent.
Doctors can reverse a major bleeding event on warfarin by administering vitamin K, fresh frozen plasma or PCCs (prothrombin complex concentrates). If some bleeding is caught early enough in a patient on Pradaxa, doctors can take the person off the pill and administer dialysis to expel the rest of the drug, which has a considerably shorter half-life than warfarin.
The lack of a reversal agent was apparently not a significant factor in Boehringer Ingelheim's massive clinical trial comparing warfarin to Pradaxa, called RELY, involving 18,133 patients at 951 testing sites in 44 countries. (The study's nifty name appears to be a contortion of one of those after-the-fact acronyms, since it somehow stands for "Randomized Evaluation of Long-term anticoagulant therapY.") The trial reported 3.36 percent "major" bleeding events for the warfarin patients, compared to 3.11 percent for those on Pradaxa. The numbers were also in Pradaxa's favor for patients who experienced "life-threatening" bleeding events (1.8 percent versus 1.45 percent).
But these numbers haven't done much to ease Houston trauma surgeon Bryan Cotton's mind.
With two of his colleagues, Cotton, an associate professor of surgery at the University of Texas Medical School at Houston and a physician-scientist in coagulation research at the Center for Translational Injury Research, penned a letter to the editor of The New England Journal of Medicine in November 2011, outlining his experience with patients on Pradaxa. (Cotton and his colleagues referred to Pradaxa by its generic name, dabigatran.)
"Currently, the only reversal option for dabigatran is emergency dialysis (as suggested in a single line in the package insert)," they wrote. "The ability to perform rapid dialysis in patients with bleeding whose condition is unstable or in those with large intracranial hemorrhages will present an incredible challenge, even at level 1 trauma centers."
Cotton is even more blunt when describing his frustration over his and his fellow surgeons' inability to stop the bleeding in some of the patients admitted to the trauma center after Pradaxa was approved. Of 11 patients he treated for severe bleeds while on Pradaxa, all but three or four died, he says.
"It's irreversible — that's a great idea; a drug that makes you bleed to death and there's no reversal agent..." he says. "So that's when we started getting both emotionally involved with it as well as academically involved."
The final straw — the decision to write to the NEJM — came, Cotton says, when two University employees were prescribed Pradaxa by doctors who didn't mention the lack of a reversal agent.
Of course, Cotton points out that as trauma surgeons, he and his colleagues see only the complications.
"We don't see all the successes with it that a cardiologist or a family-practice doc might, but it was just kind of distressing that [Pradaxa's benefits were] detailed out on this new, wonderful agent to replace the old, dirty Coumadin — and it's got all these issues that really weren't brought to the forefront," Cotton says. "And I'm not saying that they were hidden by any means from the FDA, but it got through and really no one really looked into the ability to reverse it or need to reverse it. Again, if you're talking [about] any drug that thins out your blood, why you wouldn't do something like that..."
Cotton says Boehringer Ingelheim representatives contacted him and his co-authors after the NEJM letter ran.
"They made it out that they were surprised and that they didn't have these bleeding issues with their big trials," he says. "I'm shocked that they didn't find more bleeding issues."
In response to Cotton's letter, two Canadian researchers who disclosed financial ties to Boehringer Ingelheim took up pen in defense of Pradaxa, writing that while "specific antidotes...are desirable," there was "no evidence that the lack of an antidote contributed to the deaths" of Cotton's patients.
In a brief rebuttal, Cotton raised two important, commonsense points: that despite the doctors' contention that the deaths could not be attributed to the lack of an antidote, the patients came in bleeding, and that "the multidisciplinary team caring for them could not control their hemorrhages."
And as for an antidote being "desirable," Cotton wrote: "When prescribing a drug with side effects that include life-threatening hemorrhage, reversal is not 'desirable,' it is essential."
It's just a little story, but one of the most telling things about Loraine Franklin was the way, after her death, one of her former fifth-grade students remembered her.
Franklin's daughters, Becky Hormann and Jane Ann Salazar, say the former student sent their father, Darold, a letter describing how gently Loraine Franklin had handled the student's hearing disability. Shy about his situation, the student never wanted to bring attention to himself. Without broadcasting it to the rest of the class, Franklin sat the boy near the front of the room so he could read her lips. Thirty-odd years later, the boy wrote Darold Franklin to say how much of a difference that made in his life.
There is an antidot to Pradaxa-Dagibatram.It is:Carboxocobalamin-Vitamer of Vitamin B12.
It is used,and reported to be effective in the case of Cyanide poisioning.References:Pubmed.
No reason why it should not be effective in Pradaxa-Dagibatram intoxication.
My 91 yr old Grandmother was given Pradaxa by a "top" cardiologist as if it were no problem,in fact mentioned unlike coumadin which she had been on 7 yrs prior , but moved and a Dr removed it. She was a pistol! I drove her everywhere so thats how i know this so well, There were 4 salesman with lunchs and golf tickets and speaking fees etc! I listened. Anyways in days she cant ge tout of bed!
I take her to the emergency room and she needed 4 blood and 2 plasma and ICU for weeks several times, transfusions, endless, she has many things now she neverhad, cant enjoy shopping,sleeps all the time, cant eat right, gets along on ensures they help. A GI said it was insanity to give a 90 yr old a drug with no antidote, how can a 1 size for all dose go unmonitored? especially if no antidote exists!!! I guess they figure oh well nothing we can do why check it?? everyone over 80 died or almost did and was destroyed by it making her almost helpless now.
I just don't get it, if a drug maker makes a blood thinning drug and fails to tell people that there is no antidote, how can people think something is wrong for suing the maker. For crying out loud - people die from this, while the maker generate billions of dollars and its considered frivolous to sue for the damages, injuries and lost life? No way! Kill my family & your going to pay, a corporation is basically a person now and the only way to punch them while hopefully creating a safer future is to take their money!
My the lord be with you... I lost my daddy june 23 2012.... He was on this medication for nine months.... He was bleeding inside from the chest down... No way to stop it.... I will pray for you..... Good luck
My daddy died june 23 2012 he too died from bleeding internally from this medication .. he was only 73.... They tried everything even dialysis..... He bled to death .....so yes this medication needs to go before many more people die from it... We had no warnings... So swiftright you are so wrong to pass judgement ... Hope you never lose a loved one like this.. your life will never be the same
80 year old hit head after fall and ended up with a concussion and the kids think she would have probably left the hospital with a "slight head ache"? Come on, ppl get old and they die. This is not a good example of why we need to remove a drug from the market.
Really!?!? You noticed your mom was pale and weak, but you didn't ask her to go to the doctor? This is a case of lack of education. If you put a medication...which is a chemical...in your body and do not report abnormal symptoms to your doctor, you are not only ignorant, but terminally stupid. Get a grip, stop suing for everything, and take responsibility for your own health. Be proactive in your approach, and ALWAYS BE HONEST with your doctor. This is coming from an ER nurse with 12 years of experience.
As soon as you skip that first salad, you are at a greater risk of bleeding. It's dangerous when doctors dose Coumadin according to a patient's "routine".
If you did your "homework" you would find that pharma companies do not, under any circumstances, send physicians on trips. In fact, pens aren't even allowed as of 2009. But brownie points for basing your health decisions on your independent Internet "research" as opposed to your formally educated healthcare providers.
You only left out a few things:(1) Warfarin interacts with quinolones (Levaquin and Cipro being the best-known), which are THE most popular antibiotic class around these days for things from bladder infections to sinusitis and pneumonia. Good ol' Doc gets a call from Miz Patient about that sinus trouble coming back, the anticoagulation goes out of control and guess what, here comes a major GI bleeding episode.(2) The medical literature says you can "probably" neutralize Pradaxa via dialysis. Say WHAT? Dialysis requires putting a big honkin' arterial-venous catheter in that carries major bleeding risks of its own.(3) As Obi-Wan said, "There is another". Lovenox is the third alternative for anticoagulation, and it wears off in 6-8 hours. But you have to give it via injection just like insulin and it costs a fortune.Thanks for putting this in front of the public.Stella Fitzgibbons, MD, FACP
I am a Pradaxa user and I have a point of view I hope gets considered.
At the relatively young age of 55 a routine physical revealed AtrialFibrillation. I was put on Warfarin but was never able to arrive at astable level. My pro thrombin time was all over the place. Thisnecessitated frequent testing. My veins quickly developed scars so Ibecame a difficult customer at the phlebotomist. It was a littleunpleasant.
Driving to the testing lab became a significant part of my routine. Iwonder if the expense and increased potential for mishap are figuredinto the statistics of any comparison study between Warfarin andPradaxa.
As a child I was no fan of leafy green vegetables, but when I got myadult taste buds that changed. From my 20s through my mid 50s I ateeverything green. Once I was put on Warfarin that had to stop.
I wonder how statisticians can account for the removal of leafy greenvegetables from the diet of a whole class of drug users. It’s not justthe vitamin K that you are missing. There are countless compoundsinvolved. Some of them help prevent the diseases we all become moreprone to as we age.
My cardiologist switched me to Pradaxa over a year ago. I can eat whatI want to eat again and feel better for that. I no longer have to wearlong sleeved shirts all the time to hide the bruising that comes withconstant testing. I am very fortunate that my insurance picks up mostof the cost of Pradaxa as it is ridiculously expensive.
The dietary factor; the statistical dangers of travel and the generalquality of life are all considered by the physician when he suggestschanging from one drug with drawbacks to another drug with differentdrawbacks. I don’t believe that he is snowed at all by the prettysales rep that talks up Pradaxa. He does the math; but his mathaccounts for some variables that aren’t well considered in groupstudies.
I’m not even 60 yet. Hopefully something better than Pradaxa will comealong soon. In the meantime I want to continue taking it. I think Iwill live longer and better than I would if I were forced back toWarfarin.
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I have atrial fibrillation. A well-known electrophysiologist tried to get me to switch from my $5 per month tried and true Coumadin (prescribed by my cardiologist) that has worked very well for me, to $280 per month Pradaxa. I did my homework and found out about the "no antidote" problem. I promptly told him to pound sand. I also got a new EP. You would think that his drug-company sponsored Carribean or European vacation were riding on my decision. Oh wait...
Big pharma keeps using lower rates of bleeding as an argument for Pradaxa, but that doesn't change the fact that there is no cure for it. It's easy to brush it off as a statistic until it actually happens to somebody...
#PRADAXA BLEEDS raise concerns. More www.pradaxableeds.com Should #FDA #recall?
As a geriatric social worker I am very confirmed about seniors on pradaxa. See pradaxahelpline.com
as Frances said I am dazzled that anyone able to get paid doller5846 in four weeks on the internet. have you read this
as Sherry responded I didn't know that anyone able to make doller4064 in a few weeks on the internet. have you read this
Joseph Stalin was asassinated using Warfarin. Now that's what I call a real rat poison and I'm sure the rats would agree.
My Grandmother received a informative brochure to read after we got her back from the 1st of 3 transfusions and icu stays and nothing but transfusions help.
Precisely my experience, but she is alive,just too weak to enjoy life normally now and bleeds chronically.
@Swiftright Right. Yeah effing right!!! My grandmother just died from this drug! There was nothing wrong with her until she took this poison and then she dies a couple months later from internal bleeding and kidney failure! All the side effects from the drug! They failed to make no antidote to stop the bleeding. As long as there making billions is all they care about. There are truelly devils walking his earth and the makers boelinger ingalham are one of them. It's people like u who put too much faith in the crooked government! They use humans as labrats and to become richer! Go ahead and give this pradaxa to your loved one and watch them die a month or two later. And then let's see how u feel then. Ignorance is a bliss! Good day!
I understand that, but My Grandmother was shopping 4 hours easily until this now cant go 20 minutes and needs a walker as she is dizzy all the time, headaches etc.
It almost killed her 3 two week ICU stays with numerous pints of blood and plasma, 6 the first stay alone, and transfusions inbetween. I have to be there for here every day, Which I do, but it ruined her life and health! she hads money to do anything but cant!
Nice try, but swing and a miss, I myself had called my Grandmothers cardiologist and internist, both of whom said it was to be expected and her next appt was in a few days blah blah, I read that she should have bee on hospitalized because of this drug and another one with this, I forget the name, and was sent home and calls were not ignored, just misdiagnosed and bad advice was given.. The Hospitalist that saw My grandmother asked about DNR and etc! He had never seen Pradaxa or an overdose , which he said this was!
@Singlebifem26 ? Bitch if ur were my nurse u unsympathetic miserable person I would smack the ignorant out of you. Don't come on here blaming people for trusting what there doctors prescribed them to get better. I hope u lose some one u care about due to a drug that the doctor prescribes them. Now do everybody a favor and crawl in a hole and never come out! Good day!
I am an EMT, My Grandmother is very much pto active about her health being almost vegan, walked 3 miles a day briskly and now cant without a walker!
The hospitalist was shocked! he never saw pradaxa ever yet and no overdose either and said he could do only a few things and started talking DNR!!!
It happens fast and with elderly its not that easy until late. SHAME ON YOU SIR! I WOULD SLAP YOUR FACE.
My daddy tried.... The doctors wouldnt listen... When they finally did it was too late.....again please dont pass judgement unless you have lived the nightmare i did.... Watching your father die and you cant help and there is no reversal makes your heartache
If you had any clue about the medical field you would know that direct drug marketing to MDs and PharmDs is alive and well in 2012.
While on Warfarin (from age 42 - 44), my cardiologist told me I could eat the leafy greens I enjoy...but just to do it consistently. With good monitoring and a consistent diet, we were able to keep me on my salads and keep my levels stable enough that it wouldn't cause a bleeding issue. If you consider going back to Warfarin, you might want to check with your doctor about that.
MY GRANDMOTHER WAS 90 THEN WILL BE 92 SOON!
SHE WENT VEGETARIAN 90% IN THE 1970'S AND WAS ALWAYS EXERCISING WALKING DAILY VERY BRIKLY, AND IS DESTROYED BY LACK OF BLOOD ALL THE YIME! HEADACHES , ITS BAD AND SAYING NO MONTORING IS GREAT CRITICAL THINKING THERE.
She was a very healthy 80. She did aerobics everyday and walked and enjoyed life. She had 10, 15, 20 more years to enjoy her kids and grandkids. Age is relative.
Actually she could have died today, tomorrow, next week, or the day after next Friday. She could have smoked weed and cigarettes daily and lived to be 116. Go figure.