Is Pradaxa a bad drug?

It’s crazy out there in blood thinner land.

The novel blood thinning drug for patients with atrial fibrillation, Dabigatran (Pradaxa) cannot get a break.

It’s all over the TV: Pradaxa = Bad Drug.

Look at this image:

Today, on the prestigious heart news site, theHeart.org, an insignificant 113-patient study presented as a poster at a small symposium–by a researcher with ties to anti-coagulation clinics–gets attention because a few patients on dabigatran developed well-known complications. Though the author makes important points, namely, that blood-thinners should be used cautiously and patients should be well-informed about the risks and benefits, the study added nothing to what is already known about dabigatran.

Gosh. I can’t believe I feel a twinge of empathy for a big pharma company.

Here’s a news flash:

Dabigatran and rivaroxaban are blood thinners. They lower the risk of stroke, but increase the risk of bleeding. It’s the same for warfarin. When these two agents were compared to warfarin in huge randomized controlled clinical trials, they both looked favorable.

For my entire career, I have heard the downsides of warfarin. Now, we have two drugs that prevent more strokes than warfarin, don’t require blood checks, have no dietary interactions, minimal drug-drug interactions and are not used to poison rats. Do they worsen bleeding when one falls? Yes. So does warfarin.

Folks, of course it is better to not have a disease that increases the risk of stroke. That’s what I have been saying since I started this blog. Prevention is better. Go to bed on time, exercise every day that you eat, eat less, drink fewer irritants, don’t sweat getting a B+ and smile at your neighbor. I know; these are hard therapies with which to comply adhere.

But blood thinners are not bad medicines. They are medicines. They have risks and they have benefits. And the alternative: a patient can have the disease and its inherent risks.

JMM

Comments

  1. says

    Hi John. It IS “crazy out there in blood-thinner land” as you state in your intro to this post. I honestly don’t know what the final answer is … though definite downsides DO exist to the newer agents (cost = $$$; lack of an antidote – a real problem if bleeding occurs). One of their “advantages” (no monitoring needed …) can actually be a ‘double-edged sword’ when contemplating cardioversion, since you can’t be sure (beyond the patient swearing they are taking their medication) that the patient has been adherent and is protected. That said – we all know all about the many downsides of coumadin which is far from a panacea …

    Time will tell what the ultimate answer is. Time has made me LESS likely to jump on new therapies – and I suspect the ultimate answer regarding the role of these newer blood thinners will lie somewhere in between the glorious Big Pharma promotions and the less enviable stigma on TV that you report.

  2. says

    After taking warfarin for blood clot in leg; I asked for Pradaxa. Have been taking it for almost one year. I would NEVER return to warfarin (having to make a trip to Dr. every week “trying to get the correct level and being stuck so many times; plus the limitations on what to eat and not eat”) – PRADAXA has been a blessing! I just return approximately every 6 months for complete blood work. The Hemotologist can tell exactly what is going on – I believe PRADAXA is much safer than “rat poison” and I also believe the class action law suits are for one thing only “to make money for lawyers involved” -

    • says

      It’s important–for the few readers who happen here–to know that dabigatran is not FDA approved for the treatment of leg clots. That doesn’t mean it isn’t effective, it’s just not a labeled indication.

  3. says

    It is true Pradaxa has not been FDA approved; however, I am confident that it does work and will be approved in that area soon.

    Andrea Barfoot

  4. says

    Well, I am one of the patients who takes Pradaxa twice a day; would never consider changing how I have been instructed to use this medicine. If patient is not taking according to instructions – if problems occur…..it is their fault – not the medicine’s fault –
    thus a class action lawsuit would not cover ignorance!

  5. Pete Capozzoli says

    Thanks Dr John. I was wondering what you were thinking when those lawyer advertisements for Pradaxa are on. And then there are the Google Searches that wind up on Afib blogs from what I call the “Pradaxa Nazis” who are trying to convince themselves that Coumadin is better than Pradaxa. I’m a pretty logical guy… Pradaxa works better for stroke prevention (that’s a big deal to me), Pradaxa has fewer brain bleeds than Coumadin (that is important too… brain bleeds don’t sound attractive), I can eat all the veggies I love (that would seem good for my health), take Pradaxa twice a day (have been doing that over a year now… btw, I am always intrigued by patients that don’t listen to their doctors… my doctor isn’t the one who will get the stroke… I am! Why wouldn’t I take my medicine meticulously?), do all the things that are heart healthy including getting enough sleep and exercise, eat healthy, etc., wear a medical bracelet with my AFIB condition and medications, look both ways for Mack Trucks when leaving the gym, and try to enjoy life and relax.

    I received a letter from Pradaxa saying they will honor the $30 a month price for another year.

    I feel great. Life is good. -Pete

  6. says

    I totally agree with Pete! Thanks for your positive comments. I have been on Pradaxa for almost a year and am fully convinced it works. You do need to eat properly and exercise and enjoy life and relax.

    Thanks for your comments!

    ANDREA BARFOOT

  7. Don Scippa says

    All of you left out one very important fact. Pradaxa has no off switch!! In my job working on machines, I get cut several times a month. I can’t be running off the the
    ER every time this happens and hope they can stop the bleed.
    How could a company put out a drug like that with no off switch!!

    Don S

  8. says

    Don: “maybe” you are not a candidate for Pradaxa – have you had to go to Doctor due to cutting yourself; did they stop the bleeding? Just wondering?

    Andrea B.

    • Don Scippa says

      It’s a bit of a strange situation. My Dr. wants me on this but I have yet to take it. I did
      have to get some tests done that would have not been possible while on this drug.
      I will be going to see him soon to talk with him about my fears.
      I do have Afib about once or twice a year. I was once on warfrin many years ago
      for afib and had it corrected during a heart valve repair(maze procedure). This kept my
      afib at bay for quite a while. It’s hard enough to stop bleeding even on aspirin therapy.
      I can only imagine what it would be like on Pradaxa. With all that said, I still think it’s
      a wonder drug but it scares the hell out of me.

  9. says

    A “toughie” Don – and definitely one for “an AFib doctor” (= Dr. John) given your history of MAZE procedure … Two additional factors regarding how high your risk of stroke is are: i) How often are your AFib episodes really – and how long do they really last? Over 90% of AFib episodes are asymptomatic – so even though you only have 1-2 episodes/year that you are aware of – you may be having many times more this … – and ii) How high is your risk based on other factors (as per Dr. John’s previous discussion on this blog of the CHA2DS2-VASc Score for assessing risk of stroke).

    • Don Scippa says

      I didn’t know about the asymptomatic afib other than someone that has had ablation and
      can no longer “feel” when they are in afib. I can always tell when I go into afib and it
      usually only lasts about 20 to 30 mins. My Dr. is not very forthcoming with his findings.
      I will try to pin him down next visit but I don’t think he will like that at all(very old school). Kind of a case where the Dr. knows best and the patient is given info on
      a need to know basis.I know that it’s only a matter of time and that I will need to be on blood thinners again(age plus overall condition of my heart). I may have to give up my
      job and my hobby(classic cars) just to stay alive.

      • jane says

        You should know that there’s a study involving people with pacemakers, in whom AF periods could be measured precisely, in which the half of AF patients with shorter periods of AF (average under five and a half hours) had no more stroke risk than people who had no AF at all. And if you’re only having those short periods twice a year … well, if I were you, I would sure get a second opinion before letting a doctor pressure me into taking a drug that could cause me to quit my job and give up beloved hobbies. (Are your insurance, and thereby your ability to get care for the health problems you actually have now, dependent on your job?)

        • Don Scippa says

          Yes. My insurance is tied to my job. Won’t be able to retire with medicare for another
          year and a half. I was not aware of that study, but I will bring that up with my Dr. next
          week. That’s the key. I have to find out if I’m getting afib and not able to feel it.
          On top of that I only get duration of about 20 to 30 mins each time I do feel afib.
          I need more evidence and a second opinion.
          Thanks for the advice.

  10. says

    I can not address people with pacemakers or AF patients. However, I will address blood clots in leg. By the way my Doctor did not “pressure me into taking Pradaxa” – After having 2 blood clots in my leg – I did my own study and came to the conclusion that Pradaxa would be a better drug for my condition than coumadin! No, it has not been approved by the FDA; however, I gladly have taken it for over a year with absolutely no problems and no blood clots. This drug will be approved. There are two other drugs on the market (or close) similar to Pradaxa I have been studying – I might consider trying one because you only take 1 pill a day and not 2 (that would be the only reason). It is so great to be able to eat what I want to and to not have to have blood drawn almost weekly (now it is every 6 months, and it is complete blood work).
    I think the bottom line is for someone with a clotting problem to take the drug that works the best for them. Pradaxa does that for me!

    • jane says

      If I had multiple blood clots, I’d make a trial of Pradaxa too. Even for those who don’t travel and CAN eat an invariant diet, I suspect that many of the people who are kept on a processed-food diet by warfarin are more likely to suffer harm from the diet, never mind the warfarin, than to be spared a stroke [or whatever]. But both of those drugs are being pushed, by some doctors, down the throats of AF patients who are young and/or healthy enough that their ischemic stroke risk is low enough that the predicted harm from anticoagulation exceeds the predicted benefit. (Example – when my husband was suffering from AF he was bludgeoned with stroke-risk stats that came from a study of Medicare patients with a minimum age of 65 and a mean age of 80. Stroke risk nearly doubles per decade of age. He was 51. Did we open wide and swallow? Nope, and we never regretted it, since his heart problems were reversed within a year with the aid of a plant-rich low-sodium diet.)

      • says

        The problem here is the low-risk patient who develops a stroke. These are not outliers. I have seen two patients in the last month who suffered monster strokes as a result of AF. Both had CHADS-VASc scores of big fat zeros. When one has a CHADS-VASc of zero, population statistics suggest a stroke risk of well less than 1%. That’s not a lot, unless you are the two patients described above. One cannot understand words and one cannot speak well.

        Herein lies the reason why most doctors, when asked what they would do if it was their atria fibrillating, lean towards anti-coagulation. I’m not saying they are right. I am just saying.

        Thanks for the comments all.

        • jane says

          I’m very sympathetic to their suffering. But there’s that study from a major California insurance database – I think it’s the ATRIA cohort – that found giving warfarin to younger people with a CHADS2 score of 0 provided an observed negative net benefit in terms of strokes. The researchers weighted hemorrhagic strokes as worse than ischemic strokes, based on outcomes data, but didn’t count GI bleeds or possible downstream effects of a warfarin diet as negatives – only observed strokes. There’s another large study in which the lowest-risk patients not on warfarin had a stroke risk similar to that of people without AF, ca. 1.1% per year in that group, while those on warfarin had a risk of 1.5%, implying that the warfarin might be causing more strokes than in prevented. And people who have a hemorrhagic stroke are most likely of all to end up gorked.

          These choices are also influenced by questions of personal values. One of those was whether we wanted to live our lives in fear or in hope; i.e., if taking warfarin wasn’t compatible with a lifestyle that could provide weight loss and/or improved heart health, then taking it would have meant accepting a future of certain disability and shortened lifespan out of fear of one specific type of disability, whereas we wanted to hope that he would actually get better and enjoy years of good health. Another point is that for us, there’s no such thing as a medical fate worse than death, because we have no moral objection to choosing death in such circumstances and have (we hope) ironclad advance decision directives so that we cannot be maintained against our will if gorked. Our values differ significantly from the values most doctors have been taught to internalize, and I’m afraid that a majority of the cardiologists we have encountered either didn’t understand that these are values-based decisions, or made it clear that our values, when seen to differ from theirs, were simply bad and wrong.

          • says

            Excellent points Jane. I believe the “bottom line” is that “LOW” risk is NOT the same as “NO” risk – with the sad clinical reality being that there really is NO “no risk” approach (ie, Dr. John’s 2 recent patients with stroke despite 0 CHADs score). Obvious solution to me = a collaborative, patient-oriented decision making process:

            i) Present to the patient their situation (= AFib) in the setting of whatever their existing comorbidities are (including if relevant older age and sex) – AND – present this in context to relative risk they are likely to have for developing stroke – and – likely risk of a bleeding complication (which of course changes with Pradaxa, that also changes cost vs convenience vs lack of antidote factors).

            ii) Fine to frame the above in context of what YOU (ie, the medical clinician) might do for yourself or your loved one – but being SURE to add that there is NO “right” or “wrong” answer – and that the best person to decide is the patient.

            iii) I still think relative risk is related to patient age and whether there is true “lone AFib” or not (as in totally normal echo, young age, no comorbidities) – but even then “low risk” isn’t “no risk” – albeit there probably IS a point when risk of bad bleed from a blood thinner outweighs potential benefit in a group of “lower risk” individuals.

            iv) Patient and provider both need to be aware that “Hindsight is 100% in the retrospectoscope”. That is – if no blood thinner beyond aspirin is used and the patient strokes – You were wrong. But – if you use a blood thinner and the patient bleeds – you were also wrong. NO credit is given if you are “right” (because nothing happens).

            v) That said – final “choice” should be given to the patient (perhaps with guidance if/as needed by the clinician – but with actions primarily based on what it is that the patient truly feels is best for him/her).

            vi) Anyone who doesn’t have pure “lone AFib” should be strongly recommended to take a blood thinner beyond aspirin (coumadin, Pradaxa, etc.) UNLESS there is contraindication to anticoagulation – as the data clearly favor this approach. The patient may still refuse – but informed consent can be documented, and that then is the patient’s choice.

          • says

            Jane:

            Liked your last comments very much. People do have different values regarding death. I am not afraid to die, just want the best quality of life I can have here on earth and sometimes all the medicine in the world can not give you even that!! It would be great to die without being a burden to my husband and/or loved ones but even that is sometimes inevitable and can
            be a positive experience to many!

            Andrea

  11. says

    Don:
    Another good source of information in the internet. They have information on their studies and they also have people you can call (lay people and Physicians). I also talked with my insurance company and received a lot of info. and help. Ultimately, it is your decision, but you can search the internet and learn a lot about side effects, past studies — take your information to your Physician if you feel you may want to change meds. (no offense intended to Dr.John); however, when I took all my information to the first Hemotologist he was not happy and really knew nothing about Pradaxa – I did not give up – the second Hemotologist was as excited as I was and
    knew a lot about Pradaxa. So – we work well together with Pradaxa!

    • Don Scippa says

      Already signed up for that sight and getting info together. Thanks for all your help and
      advice. Will keep you posted.

  12. Dee says

    I was discharged last night after a week’s stay in the hospital for RVR AFIB. It took the doctors two days to get the constant painful episodes (HR>200 bpm) under control. I had mild attacks in the past thinking they were due to MVP, but now, after reading these posts, I know why the docs never prescribed any meds for it.
    I am a young 53YF, non smoker, with Leiden Factor V. I have had numerous PEs and DVTs, and had been on Warfarin for well over 6 years, getting “spanked” weekly by my docs and thrown out of various clinics for not being able to stabilize my INR/Pro Times. I joined Weight Watchers to lose the excess pounds I had gained since eliminating greens, and I started recording my “ins” to no avail.
    I begged my GP, Cardio, and Hemotologist to use me as a volunteer for Pradaxa since it wasn’t FDA approved for Clotting factors. I went into a depression from the constant inability to stabilize my blood.
    It wasn’t until my assistant’s husband stroked out on Coumadin and I had tested at 4.7 (two weeks prior it was 1.3) that I decided to quit taking my Warfarin. That was 9 months ago in August.
    Since then I started eating the fruits and veggies that my 3rd grade students and I grew and prepared from our garden at school. I finally lost the weight I had gained.
    Don’t get me wrong, I didn’t throw abandon to the wind, I kept a watchful eye for signs of DVT. In fact I had a scare with a ruptured Baker’s Cyst that caused edema and pain in my left leg.
    I am finally on Pradaxa, Yeah! I feel it is a personal decision that a patient and a doctor should agree upon. But the docs need to “listen” to the patient. Sometimes the pros out weigh the cons. In my case I feel a lot of my grief could have been prevented. Kudos to you Andrea.

  13. says

    Dee:
    I am so glad you have persevered with your Doctor’s. I have found that there are not too many doctor’s who really “listen” to their patients! If I were a person who took every physician to court over “mistakes” they have made affecting my health – probably would be financially over the top, especially with many of the attorney’s who dig up these class action law claims. I have been approached for many different meds and procedures that “attorneys” file class action claims and usually win – However, I don’t believe in these law suits, unless it is something blatantly bad. I
    usually just tell the doctor (or his nurse, because you can’t really get to the doctor)
    what they did that adversely affected me. Of course, there is no response and I don’t see them again. My choice (which probably makes them very happy).

    When you find a good doctor (and there are many) KEEP HIM OR HER for as long as you can!
    Andrea