By Sean Pendergast
By Sean Pendergast
By Jeff Balke
By Richard Connelly
By Jeff Balke
By Casey Michel
By Craig Hlavaty
By Jeff Balke
Franklin taught for 30 years and stayed active in retirement, her daughters say. There were the stamp club, Bible reading, church committees, the Red Hat Society; she even went for strolls with friends in a dog-walking group, even though she didn't have a dog.
A decidedly upbeat, positive person, Franklin never complained, which is why Salazar says it was a surprise when she saw how her mother answered the door a few weeks before she passed away. Salazar says she had come to tend to her father, who had recently fallen. Salazar says Franklin was stooped over, so weak she couldn't stand straight.
"I wasn't even coming for him anymore — it was for her," she says.
Franklin's daughters say that, while Franklin never wanted to burden her family — or apparently even her doctor — with her health concerns, she did confide in a close friend.
Salazar says that after her mother passed, the friend disclosed that Franklin had told her that "she didn't know if she could take this pain anymore."
The daughters say they didn't even know Franklin was on Pradaxa, which they say she had started taking in June, six months before she died. It wasn't until the night of her fall, they say, when doctors explained about the irreversible bleeding, that they were told. Afterward, when the daughters were sorting through Franklin's belongings, they say, they found tampons and maxi-pads. Quite a surprise for an 80-year-old woman. They believe she'd been bleeding all along.
Her daughters believe the bleeding had made their mother weak, leading to the fall that because of Pradaxa was fatal. They feel the drug robbed them of maybe ten more years with their mom.
"I would not give Pradaxa to my dog," Hormann says.
Lead attorney Mikal Watts is even more cynical, accusing Boehringer of rushing what it knew was a defective drug to market.
"The RELY study is completely cooked," Watts says. "Boehringer released the study to enable it to sell two to three years of Pradaxa before the real data would mandate its recall from the market."
A veteran of pharmaceutical lawsuits — he has won big verdicts in cases against the manufacturers of Vioxx, Ortho Evra, Rezulin and others — and a man who knows his way around a soundbite, Watts says, "I have seen bad drugs on the front end and seen the inevitable recall that will follow. Pradaxa is the worst drug I have seen, and there is no doubt in my mind that they will be forced to recall it in order to stop the serial killing of Americans that are on this bad drug."
Watts hasn't filed anything in court supporting his contention that RELY was cooked, but the study has taken some heat in the two years since its release. Even Boehringer's own chest-thumping over the study begs a closer look at its claims, such as when Boehringer spokesperson Emily Baier pointed out RELY's findings that, compared to warfarin, dabigatran reduced the risk of stroke by 35 percent.
Sounds amazing. And it's mathematically accurate. But in context, it loses some of its luster: The RELY study's rate of stroke among dabigatran patients was 1.11 percent (134 people), and the rate was 1.69 percent (199 people) for those on warfarin.
But John Smith, Boehringer's senior vice president of clinical development and medical affairs, believes the reduced stroke rate has real-world significance. And while the RELY study showed a higher risk of gastrointestinal bleeding among those on dabigatran, it showed a lower rate (59 percent) of intracranial hemorrhage.
"That's really...kind of the trade-off in terms of one type of bleeding versus another," Smith says. "And clearly, intracranial hemorrhage is a very devastating event for a patient and their family. It leads to death about a third of the time and significant disability a large proportion of the time as well, if you survive."
When asked about Cotton's complaint that there is no way to monitor a dabigatran patient's blood, Smith says there actually is a readily available test — a curious stance, given that one of Pradaxa's chief selling points is that unlike with warfarin, a patient doesn't have to undergo regular monitoring.
Smith says the test — called "activated partial thromboplastin time" — would be useful for a physician who's concerned with a patient who's already bleeding. Even more confusingly, Smith also says it provides a way to "follow the reversal of Pradaxa." In this context, "reversal" means discontinuation of the drug, or possibly dialysis, in the absence of the type of life-threatening bleed that trauma surgeons like Cotton are concerned about.
This is why, when told about Smith's contentions, Cotton wrote in an e-mail: "He obviously doesn't practice medicine on the planet Earth."
Franklin's daughters might also be surprised by Smith's perspective, especially surprised to hear the line about the lower risk of intracranial hemorrhaging, since they believe the blow to the head she sustained in the fall is what killed her.
"It's just scary to think that she could be sitting here right now, you know? It just bothers me," Salazar says.
As the lawsuits against Boehringer continue to pour in, so do new claims from doctors and watchdog groups questioning the reliability of the RELY findings in the real world.
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 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.
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.
@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!
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.
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
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.
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.
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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.
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.
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