Pradaxa Patients Can't Stop the Bleeding

There's only one really bad thing about the anti-clotting pill Pradaxa. You can't fall or get cut while taking it because once you start bleeding, there's almost no way to stop it. There's no reversal agent, no antidote.

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Less than 24 hours after Loraine Franklin fell on the kitchen floor of her Georgetown home, she was dead.

Loraine Franklin died eight months before her 60th wedding anniversary.
Courtesy of the family
Loraine Franklin died eight months before her 60th wedding anniversary.
Franklin's daughter Becky Hormann says her mom would be alive today were it not for Pradaxa.
Troy Fields
Franklin's daughter Becky Hormann says her mom would be alive today were it not for Pradaxa.

It was December 29, 2011, and Franklin's daughters say today that, had Franklin, 80, not been prescribed a blood thinner called Pradaxa, she'd have lived to see the new year and subsequently celebrate her 60th wedding anniversary.

Instead, they say, the fall caused a blow to her head, which caused an intracranial hemorrhage, which doctors at the hospital could not stop. All the doctors could do, the daughters say, is make Franklin as comfortable as possible as her speech became slurred and the blood pooled in her skull.

Like hundreds of thousands of others with a heart condition called atrial fibrillation, which raises the risk of stroke, Franklin had been told of the benefits of the recently FDA-approved Pradaxa over its comparatively ancient counterpart, Coumadin. What she hadn't been told about, according to her daughters, was Pradaxa's most significant drawback: There is no effective reversal agent for a traumatic bleeding event.

Had Franklin been taking Coumadin — as she had years before — she would have left the hospital with a headache and a slight concussion, her daughters say. With Coumadin, doctors have a variety of ways to keep a patient from bleeding to death. Instead, according to Franklin's daughters, Pradaxa turned a simple fall into a death sentence.

Which is why Franklin's daughters are suing Pradaxa's German manufacturer, Boehringer Ingelheim, in federal court. They say the company did not adequately warn doctors and patients of the lack of an antidote. They're just two of dozens of clients represented by the Texas law firm Watts Guerra Craft, whose mass-tort team opened the floodgates by filing the first Pradaxa-related cases in November 2011.

The timing coincided with Boehringer's announcement that it had recorded 260 Pradaxa-related fatal bleeding events worldwide between March 2009 and October 2011. The FDA followed suit by announcing a post-market safety review. Regulators in Japan had already asked Boehringer to issue "Dear Doctor" letters to health-care professionals warning of the bleeding risk, and Australian regulators issued a safety advisory as well.

However, the FDA, per its announcement, "continues to believe that Pradaxa provides an important health benefit when used as directed," and Boehringer representatives told the Houston Press that 260 recorded deaths are not outside the parameters of a major clinical trial that the FDA and its global counterparts relied on in approving the drug in the first place. Company representatives also say the risks were not hidden or minimized.

Pradaxa has been a boon to Boehringer's bottom line. But if Loraine Franklin's daughters get their way, the drug will be off the market — just not soon enough for their mother.
_____________________

If ever there was a drug that could use a makeover, it's warfarin.

Warfarin (brand name Coumadin) was introduced to the marketplace in 1948 not as a medicine but as a rat poison. Six years later, probably to the surprise of rats as much as anyone else, the FDA approved warfarin as an anticoagulant, and it remained the choice of treatment for patients with a type of irregular heartbeat — atrial fibrillation — for more than 50 years.

The most common type of arrhythmia, atrial fibrillation occurs when one or both of the heart's upper chambers do not beat in sync with the lower chambers. With blood flow disrupted, clots can form, which can lead to heart attack and stroke. The U.S. Centers for Disease Control and Prevention estimates that about 2.6 million Americans currently suffer from atrial fibrillation; the CDC predicts the number will grow to 12 million by 2050. (The median age is 66.8 years for men and 74.6 years for women.)

Medically speaking, warfarin is what some physicians refer to as "a pain in the ass." It interacts negatively with a legion of other drugs, and because it works in part by interfering with vitamin K, patients have to avoid any foods high in that vitamin like leafy greens, liver, green tea and cauliflower. Patients' blood must also be regularly monitored — once every three or four days at first, then once or twice a month; the test, known as the International Normalized Ratio, measures how "thick" or "thin" a patient's blood is. Too thick, and the patient is at an elevated risk of clotting; too thin, and the higher the risk of bleeding.

Even the nonprofit watchdog group the Institute for Safe Medication Practices — which never has a shortage of what it considers frightening new Pradaxa statistics — is blunt when describing warfarin's risks.

According to the institute's April 2012 report, "Inhibiting the blood clotting process in elderly patients ranked as one of the highest risk outpatient drug treatments in all of medicine, with the leading agent, warfarin, accounting for 33 percent of all emergency hospitalizations for drug adverse effects in the elderly patient population."

Yet because of its low cost and respectable success rate (given the complications), this highly annoying, inconvenient treatment has been the standard-bearer for the treatment of atrial fibrillation. In the mid-2000s, however, no fewer than eight pharmaceutical companies took a fresh look at this market, estimated to be worth $10 billion-$20 billion.

In 2010, Boehringer, a 120-year-old family-owned company, beat everyone to the U.S. market with Pradaxa. According to the FDA, approximately 1.1 million prescriptions were dispensed between October 2010 and August 2011; an estimated 371,000 patients filled their prescriptions from outpatient retail pharmacies during that period.

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43 comments
doreenlolaharner
doreenlolaharner

I landed in the hospital after being on Pradax for 2 years with ulcers and needed 5 pints of blood and almost died. I wonder how much my near death experience is worth to them. Almost passed away 6 years prior and almost lost my leg due to what a surgeon that was here in PA from California said was the largest blood clot he thinks ever operated on.They asked for my case history and all the surgery rights so doctors could put my "blood clotting" surgeries in teaching text books. I gladly did to help others. So they saved my life and put me on blood thinners that almost took my life????  Fed up with being so sick. Probably going to land in the hospital again because since feb last year when I originally had to get the 5 pints of blood I AM STILL BLEEDING and not allowed to be put back on blood thinners because I am still bleeding which in turn causes me to be a high risk for blood clots, stroke and heart attacks...Couldn't be any happier. Still waiting to hear back from the lawyers I "hired" to handle my Pradaxa case just an occasional letter stating they're working on my case...Is this really living.

kdgrayson
kdgrayson

Wrong, it is nothing like Wayfarin, it impedes clotting. There is no antidote.

dubrawsky
dubrawsky

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.

Chimmy
Chimmy

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.

injuredme.co
injuredme.co

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!  

Blonde24426
Blonde24426

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

Blonde24426
Blonde24426

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

Swiftright Right
Swiftright Right

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.

Singlebifem26
Singlebifem26

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.

Neasy123
Neasy123

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".

Ashleythompson
Ashleythompson

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.

Robert Fisher
Robert Fisher

I do not take any of anticosgulation drugs yet. My Doctor said I have AFIB. but I feel ok.

Stella Fitzgibbons, MD, FACP
Stella Fitzgibbons, MD, FACP

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

Donald Kortum
Donald Kortum

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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Mad Chad
Mad Chad

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...

Carol Zhu
Carol Zhu

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...

http://www.newsinferno.com/pha...

Meadows Troy
Meadows Troy

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kerrryz
kerrryz

Spare us from ambulance chasers and their uneducated plaintiffs.

Meadows Troy
Meadows Troy

as Sherry responded I didn't know that anyone able to make doller4064 in a few weeks on the internet. have you read this

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Shamrock
Shamrock

Joseph Stalin was asassinated using Warfarin. Now that's what I call a real rat poison and I'm sure the rats would agree.

doreenlolaharner
doreenlolaharner

@Chimmy So sorry to hear about your grandmother I was only 43, last year and dealt with the same problems and like your grandmother I also sleep all the time, can't eat and lost so much weight because the Pradaxa caused me to get ulcers that won't stop bleeding even after being off the Pradaxa for damn near a year. I think the medication did something to us that we don't even know about to be so sick still with the same symptoms afterwards. It's a shame when people like her and I get so sick we need such meds and then we have to have near death experiences because they want $$$$ that's all the Pradaxa was about they looked and found a way to get one of the largest prescribed life sustaining medication and marketed it SAFE & NOT needing any testing which we all know is very hard for sick people to go do , told us it was safe knowing all they were concerned about was making money. Nowadays, I've learned we can't just count on the doctors to prescribe us medication without having to research EVERY thing they give us first...It's just sad...then a check is supose to make this all go a way I say keep the check and give me back the last 2 1/2 years plus the future ones because all I do is sleep and never feel energized ever. That medication does far more damage to us than needing blood and plasma does your grandmother have any ulcers?? What made her not want to eat after her dealings with  the pradaxa? What caused or where did she bleed from?? AHH, I'm sorry I'm just sadden to read others stories as it is so much like mine and I can relate...I keep asking myself why after a year am I still going through what the Pradaxa started and caused especially because I'm not on it for almost a year now. If coumadid put rat poision in their medication what the hell did Pradaxa use???

I will keep your Grandmother in my prayers what is her first name?? God doesn't need names but praying I like to it makes it more personal, ya know. Good luck and God Bless her and her family as it effects many more than the person it was prescribed for. 


Chimmy
Chimmy

 @injuredme.co

 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.

Chimmy
Chimmy

Precisely my experience, but she is alive,just too weak to enjoy life normally now and bleeds chronically.

Speakingthetruth
Speakingthetruth

@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!

Chimmy
Chimmy

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!

kdgrayson
kdgrayson

@Singlebifem26 

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!

Speakingthetruth
Speakingthetruth

@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!

Chimmy
Chimmy

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.

Blonde24426
Blonde24426

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

Chimmy
Chimmy

SPEAKING ENGAGEMENTS/FEES, GOLFING,M DINNERS YES THEY DO, LUNCHES TOO!

Swiftright Right
Swiftright Right

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.

Ogg Andrea
Ogg Andrea

Hi Donald,

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.

Chimmy
Chimmy

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.

Beckyhormann
Beckyhormann

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.

obamasucksdic
obamasucksdic

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.

Chimmy
Chimmy

LOOK AT THE TROLLS HANDLE ITS Kenxx of craigslist!!!

 
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