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The Pradaxa Conundrum – Blockbuster Drug Associated with 459 Deaths?

13 comments

What am I missing here? The number of reported injuries arising from use of Pradaxa continues to grow at an unparalleled pace and yet financial and pharmaceutical analysts celebrate Boehringer Ingelheim as profits on its blockbuster drug, Pradaxa, continue to surge.

In the last three months of 2011, the FDA collected 3,000 reports of adverse events for Pradaxa, earning Boehringer Ingelheim’s blockbuster drug the fifth spot on the Top Ten Drugs with the Most Adverse Reports List for 2011 Q4. Of those 3,000 reported adverse events, 459 deaths, 69 disabilities, and 1,331 hospitalizations resulted – making it the drug with the most associated deaths for the quarter.

Meanwhile, Boehringer Ingelheim is enjoying an increase in after-tax profits by 66% and sales increases of 5% as the financial and pharmaceutical journals attribute a large percentage of the increased sales to Pradaxa which officially graduated to “blockbuster” status as a result (blockbuster status is defined as generating annual sales of $1 billion or more).

Where is the disconnect? Why is this drug selling at such a high rate given all the negative press out there?

Source: AdverseEvents Monitor

13 Comments

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  1. Steve says:
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    Was curious to know if anyone can answer how many reported deaths have occurred from Warfarin. I heard a lot of Doctors don’t report adverse events anymore from Warfarin because it has been around for so long. I’m curious to see if anyone can answer. I’m certain so many people die on Warfarin everyday all around the world but no one seems concerned.

  2. Ross Young says:
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    Steve with Coumadin, it’s very hard to say. Many people have listed, as their cause of death being Coumadin related, but the fact of the matter is, not many professionals understand how to dose the drug properly. I see it every day. The best answer I can give you comes from a certified anticoagulation expert, Algha Lodwick, who is now retired.

    “32

    1998 = 12

    1999 = 17

    2000 = 39

    2001 = 39

    2002 = 27

    2003 = 44

    2004 = 46

    Total = 224 over 7 years for an average of 32 per year.

    This is data from death certificates listing this as the cause of death.

    There were an estimated 30,600,000 prescriptions filled for warfarin in 2004. This is an estimated increase of 45% from 1998.

    So for every 10 million prescriptions filled for warfarin, approximately 1 person died with the primary cause of death being anticoagulation.

    Reference: Wysowski DK et al. Bleeding Complications with Warfarin Use. Arch Intern Med. 2007;167:1414-9″

    If professionals would learn to dose the drug properly, patients would be compliant, I’m sure you’d see the Coumadin death rates fall like a rock. At least Coumadin has an antidote, which cannot be said for Pradaxa.

  3. Ross Young says:
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    Sorry, I forgot to post the question Al had asked.

    “BETWEEN 1998 AND 2004 AN AVERAGE OF HOW MANY PEOPLE PER YEAR

    IN THE UNITED STATES BLED TO DEATH FROM ANTICOAGULATION?”

    http://web.archive.org/web/20100326053600/http://www.warfarinfo.com/default.htm

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    There is a risk of bleeding associated with all anti-anti-coagulants including aspirin. Patients on Coumadin (warfarin) ARE at an increased risk for cerebral bleeds. And, if a patient on warfarin sustains a serious traumatic events, that patient has an increased risk of serious morbidity or even mortality as a result.

    But….if a patient on warfarin is in an auto accident and suffers internal bleeding, or if that patient sustains a laceration, even a mild laceration, the ER docs have several treatments available to them to treat the bleeding including surgical consults, vitamin K, plasma, blood……

    If you are on Pradaxa, there isn’t any reversal agent. Vitamin K doesn’t work. Plasma doesn’t work. The surgeons can NOT cut the patient open to get to the bleeding.

    In one major university medical center 10 ‘trauma’ patients on Pradaxa were recently seen. Nine of the 10 patients ‘bled out’.

    One patient was seen with a cut EAR. The surgeons spent three days and 50 units of blood in order to save his life.

    If a patient is on Pradaxa they cannot sustain a laceration. They can be in an auto accident. They cannot fall, hit their head and sustain a subdural hematoma. They cannot sustain an injury requiring neurosurgical intervention.

    If they do….they’re dead.

    It is unconscionable for a pharmaceutical company to put such a drug on the market in 2012 without any reversal agent.

    As the neurosurgeon Peter Teddy wrote: “It is only a matter of time before we see case reports of irreversible bleeding during dabigatran-treated surgical emergencies and urgent attention must be paid to the provision of an effective, rapidly acting antidote. Surely it is irresponsible of any pharmaceutical company to release such a drug into the market and promote it extensively as a potential life-saving replacement for existing therapies without fully detailing the very real risk of irreversible hem-orrhagic complications following trauma or at emergency surgery, no matter how small the numbers at such risk may be.
    These patients cannot be regarded simply as collateral damage.”

    John M. Restaino, Jr. DPM, JD, MPH

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    The numbers are just frightening.

  6. Dr. Jim says:
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    A couple of quick comments – to Dr. Restaino: If a patient on warfarin needs emergency reversal, vitamin K will take 15 to 17 hours to reverse warfarin. Pradaxa has a half life of 12 hours. So in reality, you end up in the same situation – you cannot do anything immediately to reverse warfarin – so practically speaking, in an emergency situation, you do not have an antidote for warfarin in reality. Second and more importantly, the data on Pradaxa shows it significantly reduces intracranial bleeds and hemorrhagic strokes both of which are high with patients on warfarin and can be devastating. Physicians have to make choices everyday – the benefits of Pradaxa (in significantly reducing strokes) far outweigh the risks we take everyday with warfarin and placing the patient sometimes on sub optimal therapy. All products come with side effects and potential risks – physicians have to be educated and manage those risks better to provide the greatest benefits to patients.

  7. Ross says:
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    Dr. Jim, your leaving out fresh frozen plasma along with vitamin K as a rapid reversal agent. I’ve needed rapid reversal twice in 12 years. Had I been on Pradaxa, I would be dead today. Even with a half life of 12 hours, that is too long when your having a major bleed event. That kind of risk is totally unacceptable to me.

    I think why so many doctors prefer to put patients on Pradaxa is because it relieves them of responsibility and places it on the patient.

    I can ask 5 different doctors a Warfarin dosing hypothesis and I’ll get 5 different answers every time. The problem with Coumadin is not the drug. It is those managing it and patients that are not compliant or sick of being vein stuck and never being in range more then 55% of the time. I’m watching someone right now going to a Coumadin clinic, being tested every 2 days, dose being changed just as often as tested and this is going on the third week and he’s still not even close to in range. Why? Simple. Testing before the first dose has had a chance to reach it’s peak effectiveness, the dose being changed constantly, which does nothing more then create a yo yo effect. What I’d like to see is standard dosing protocol followed by every physician. If that were implemented, which I don’t think will happen in my life time, it would do wonders for the negativity about Coumadin. Not only that, but there are still professionals out there scaring the living daylights out of their patients with misinformation about the drug.

    Patient self testing and self management would, in all likelihood, cut the number of deaths and increase the number of in range times.

    I’d love to have Dr. Jack Ansell weigh in on this topic.

  8. Jim says:
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    Response to Ross – appreciate your comments – perhaps a paper published just this week in STROKE (May 3rd) by Dowlatshahi, et al on behalf of the Canadian PCC registry investigators may help

    http://stroke.ahajournals.org/cgi/content/abstract/STROKEAHA.112.652065v1

  9. Ross says:
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    Jim appreciate your comments also.

    One has to wonder what the outcomes of those patients would have been had they had no anticoagulation at all. I’m willing to bet that they would have still had poor outcomes. This is one area that I don’t think, regardless of how many studies are done, will ever give the honest result. They based that study on older patients, which we know are prone to weakened vessels from the natural aging process. Given the time frame that Pradaxa has been out, who can really say for sure that it doesn’t have the same effect? We won’t really know for years yet. Meanwhile, we do know that Pradaxa has proven to show an increased risk of Myocardial Infarction and Acute Coronary Syndrome and an unusually high death rate for a drug that hasn’t been out very long.

    I don’t think they studied the drug long enough or the FDA simply inked the OK without really giving it much thought when they allowed Pradaxa to go on the market.

    Never the less, my whole point revolves around the fact that there are far too many professional managers/clinics/doctors that have no clue how to dose Coumadin/Warfarin. Europe is light years ahead of the U.S. in this field.

    The drug has been out for over 50 years. You’d think by now, there would be a standardized protocol for dosing, yet I cannot find but a handful of places or people that know how to manage Coumadin properly. If everyone were managed properly and patients were compliant,I know there are some who are not, could you imagine how the number of deaths from Coumadin would drop?

    Trying to answer Steve’s question is difficult because of all the possible scenarios involved. I believe many times, anticoagulation is blamed for something simply because a person was taking it. Again, I wonder what the outcome would be if they weren’t on it. I don’t think we’ll ever be able to answer that one with any degree of certainty.

  10. Ross says:
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    Here is a gentlemen that’s been on Warfarin for 51 years. There is a lot to be learned from people like him.

    51 Years On Warfarin Congratulations RCB-10/27/2011

    http://www.heartvalvepatients.org/hvp/showthread.php?t=1322

  11. lisa Spitzer says:
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    I am a Geriatric social worker and worry about seniors on Pradaxa.The blood vessels in the Brain become extemely fragile with the aging process. With poor balance seniors are prone to falling bumping and head injury. Many seniors live alone and do not keep good records of medications. If a senior fractures a hip while on Pradaxa emergency surgery could be fatal. Our Pradaxa helpline can be reached at 1 877 522-2123

  12. Randy says:
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    Beware Pradaxa Users:

    Our Father during January 2012, came into the research Hospital, Doctors took my father off Pradaxa and waited 36 hours (24 hours per Per Drug Company) to have a procedural tap done on his lung, short period after being sent back to his hospital room he collapse, within minutes after rushing him to icu he coded with crack ribs and all, recover, doctors notice he was bleeding inside out from the lung tap and perform a chest tap to release the blood formation from outside of the lung, he coded again and was revived, some 20 to 30 of our country top doctors were involved in the icu trying to save my father life, the doctors were lost, they ended up flooding his body with units of blood for days until the lung stop bleeding inside out, the doctors realize his organs (kidney, heart, etc) would be damage from the over flooding of blood, he made it thru without brain damage but had to live on a breathing tube for over three weeks in icu, after three weeks his organs were shutting down, medical staff tried everything to help him survive, he finally realize his time on this was very short, but for him and his family to suffer for over five weeks, to finally here the doctors say he is finished he had lost his battle, the family made the decision to let him go peacefully, for over four days the family sat with him around the clock waiting for him to pass on, on his last day our mother went in to see him to say it is ok for you to go and told an inside joke between our parents was we have seven brats to take care of mother, they were married for over 59 years, my father squeeze my mother hand while he was under from the drugs and pain killers, mother went back to her hospital room, hour half later while my sister was holding his hand the iv drip waring bell was ringing next to his bed where my sister (register nurse) was sitting as she got up turn the warning bell off she notice the screen said near end (iv bag empty), as she sat down to call the nurse my father squeeze my sister hand looking at her with wide eyes seconds later he closed them and passed away with his last breath of air.

    Please share this with your families,Pradaxa is a very dangerous drug to be taking.