The blood-thinning drug Pradaxa made headlines Thursday when a New York Times article by Katie Thomas blew the lid off insider communications. The scandal hit the fan because a federal judge in Illinois released drug company documents revealing that the manufacturer knew about Pradaxa complications, but went out of its way keep them under wraps.

The bottom line: Pradaxa can cause life-threatening hemorrhages if the dose isn’t spot on. It’s not always easy to tell when the dose is correct. As a result, doctors are often flying blind.

Visitors to our website have been asking about the safety of Pradaxa for years. Here are just a few of the questions we have received:

Q. I have recently been diagnosed with Stage III Kidney Disease by a nephrologist. I also have A-Fib [atrial fibrillation] diagnosed by my cardiologist.

My problem is that the cardiologist suggested I take magnesium to help with sleep and my heart. I am reading in your Guide to Home and Herbal Remedies that too much magnesium could cause further damage to my kidneys.

I take Pradaxa (75 mg) twice a day along with propafenone for my heart, valsartan, Estrace and hydrochlorothiazide.

Is there anything else I need to do to keep my kidney disease from getting worse? Otherwise I am in good health.

Gayle

A. Gayle, although you are taking a reduced dose of Pradaxa (which is appropriate for patients with kidney disease), there is the potential for overdose. Older people often have reduced kidney function and you clearly do. That is why you are walking a tightrope when it comes to dosing. If Pradaxa [dabigatran] builds up in your system you could be at serious risk for bleeding. Symptoms to be especially alert to include:

       SYMPTOMS OF BLEEDING

  • Unusual bruising (bruises that show up without any obvious cause)
  • Nose bleeds
  • Bleeding from gums that is worse than usual
  • Bleeding from a cut that will not stop within a reasonable amount of time
  • Urine that has a pinkish or brownish color
  • Stools that look red, black or tarry
  • Coughing that brings up pink flecks of blood
  • Vomiting blood or vomiting anything that looks like coffee grounds
  • Headaches, dizziness, weakness
  • Unusual joint pain, swelling or discomfort in a joint

Such symptoms are extremely serious and require immediate medical attention.

One final note, Gayle, magnesium can be dangerous if you have kidney disease. Please discuss this with your nephrologist.


Q. I just got back from Ohio helping my Mom who was suffering serious fatigue. She ended up in the hospital from internal bleeding due to an interaction of Celebrex and Pradaxa.

Five different doctors did not mention this combination could be a problem. Why do doctors not have more info about drug interactions?

Pat

A. Pat, your mom was lucky she survived her internal bleeding episode. Her doctors should have warned her that taking a drug like Celebrex that can irritate the digestive tract and cause ulcers is quite dangerous in combination with an anti-coagulant like Pradaxa. If an ulcer does occur, it can lead to internal bleeding. Whenever this happens, it is a life-threatening situation. Doctors should be well informed about such interactions and always warn patients what to watch out for. The pharmacist should have caught this potential problem as well.


Q. I was diagnosed with A-fib several months ago. I went to my primary care physician first and he prescribed digoxin for the A-fib and nattokinase for stroke prevention. He then referred me to a cardiologist, who kept me on digoxin but prescribed Pradaxa for stroke prevention.

I have two concerns. One is that every time I watch television for more than an hour, I’m being urged to call an attorney and sue Pradaxa because of possible deadly side effects. The other is cost: Pradaxa is $225.00 a month and my insurance doesn’t cover it. So I’m concerned about both safety and cost.

Is Coumadin [warfarin] a better and much less expensive way to go? How much blood work is required if I take Coumadin? Is there anything else out there that will prevent clots but doesn’t cost so much?

Bob

A. You have asked a complex and intriguing question, Bob. Doctors used to primarily rely on warfarin (Coumadin) to prevent blood clots from forming and triggering strokes. Then along came Pradaxa.

One of the big selling points for the new anticoagulant was that unlike warfarin, it did not require frequent blood tests. This “benefit” led doctors to prescribe Pradaxa to over 800,000 patients. Last year alone, Pradaxa earned more than $800,000,000.

But here’s the rub. By monitoring warfarin levels, doctors can adjust the dose to try to avoid under-treatment that might lead to blood clots and strokes or over-treatment that might lead to fatal bleeding episodes. Without a similar test to monitor Pradaxa effectiveness, it is more challenging for physicians to hit the sweet spot. It is estimated that there have been more than 1,000 deaths linked to Pradaxa.

The current scandal surrounding the drug is all about internal documents at Boehringer Ingelheim (the manufacturer of Pradaxa). A researcher at the company seemingly suggested that careful blood monitoring would allow physicians to adjust the dose of Pradaxa so it could prevent strokes without leading to hemorrhage. But this would have upset the marketing advantage over warfarin or other new anticoagulants. In other words, Pradaxa wasn’t supposed to need testing. That was its big selling point.

The unanswered question is whether marketing trumped patient safety. That is the crux of the thousands of lawsuits that are now pending. Did the drug company reveal the complexity and dangers of taking Pradaxa?

We’re not lawyers, so we will not dabble our toes in that water. But we would like to hear about your experience with Pradaxa or other anticoagulants. Share your story below in the comment section.

        SIDE EFFECTS OF PRADAXA & COMPLICATIONS

  • Bleeding, hemorrhage
  • Heartburn, reflux, indigestion, digestive distress, abdominal discomfort, gastritis
  • Rash, itching, allergic reactions, anaphylaxis
  • Blood disorders

        A WORD OF CAUTION ABOUT STOPPING PRADAXA

  • Never stop Pradaxa without medical supervision!
  • Never stop Pradaxa suddenly. Doing so can trigger a rebound hypercoagulable state that could lead to blood clots and an increased risk of stroke
  • If Pradaxa must be stopped for a reason other than life-threatening hemorrhage, a physician will need to substitute another anticoagulant and make the hand off cautiously to prevent either bleeding or blood clots from forming

Again, please share your own story with Pradaxa or any other anticoagulant so that others can benefit from your experience.

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  1. Nancy F.
    Raleigh NC
    Reply

    I have Afib and am very impressed with extensive research I have done on the long-term effectiveness of Nattokinase as a blood thinner! Yet, I find almost no info endorsing it in general medical sources. Asking your medical provider is laughable. They look at you like they have just been hit in the head with a board.

    It’s a Japanese enzyme successfully used for centuries for lowering blood pressure and thinning blood to prevent clots. So, it hasn’t had clinical trials! Lots of meds that have trials are prescribed and end up killing people. Would you please publicize some reliable information about this. WebMD is a good starting place, You can do your public a great service by revealing this enzyme.

  2. Mamoon
    Toronto
    Reply

    I am very depressed with the information.

  3. marie b.
    st paul mn
    Reply

    Just started Pradaxa Monday. Day 1 – 3 headache, mostly gone day 4. Day 3 and though today, day 5, swollen painful knees and my right leg is more swollen than my left. Itching here and there also. Day 1-2 only took one 150 capsule. Day 3-4 took two capsules each day. Day 5 I took only one capsule. I already dislike Pradaxa. I have to use an anticoagulant ‘cuz I have had 2 pulmonary embolisms and 1 dvt. Changed from warfarin because of side effects. the side effects of which could cost me my job because I could not think right, memory problems. Made so many errors… looks like Pradaxa ain’t much better.

  4. fbl
    Reply

    dhs, I am probably not the best source as I seem to have problems with a lot of meds. I can say that Xarelto caused me excruciating pain in my thighs and calves and in fact the muscles wasted terribly. It also caused me the runs which I still have problems with today 2 1/2 years later. I only took the med for about two months.
    My family Dr. did acupuncture and my muscles are almost filled out again but I still have gnawing achy pain and weird feelings of bubbles in the leg muscles.
    The diarrhea is still a problem and it has taken three different remedies to keep it almost in check.
    What I have successfully done for blood thinning is take nattokinase, serraptase and cayenne capsules 2X a day. I also take 1200 iu of vitamin E, mixed tocopherols and tocotrienols, daily as well as Omega 3 (in cod liver oil and krill oil. I do NOT take aspirin or any other blood thinner of blood pressure med.
    These natural remedies have worked for me and I have had no more heart attacks or strokes since I’ve been doing this regimen-about 2 1/2 years.

  5. dhs
    Reply

    I would be curious how this person, or others, have fared switching from Pradaxa to Xarelto as I am about to do so at Doctors recommendation?

  6. Wendy B.
    Reply

    I was diagnosed with A Fib on April 4, 2008 and have been on warfarin ever since. When Pradaxa first came on the scene the main thing I didn’t like was the lack of frequent testing of the blood. Recently my blood became quite thin but because I have an INR test once a month my doctor was able to adjust the dosage of warfarin and check it regularly until it got back to normal. The other neat thing is that warfarin costs me a little over $30 per month. A pharmacist has told me that Pradaxa and some of the other new anticoagulants are extremely expensive. As my sister says, I am vindicated for refusing to change to Pradaxa.

  7. Don
    Reply

    Because Pradaxa and Xarelto work similarly, would the same concerns about Pradaxa be applicable to Xarelto? I switched from warfarin to Xarelto one year ago because my INR was behaving like a yo-yo after years of great stability. However, my doctor orders blood work every six months to monitor renal function.

  8. fbl
    Reply

    During an auto accident, the shoulder harness damaged my heart. To prevent clots I was given a number of different meds (and shots in the belly)that did not work. The last one, Xarelto, has caused me serious problems. Destroyed muscles, muscle pain and diarrhea were the worst.
    My family Dr. did a series of acupunctures which did bring most of my calf muscle back but now two years later I still have problems with the diarrhea.
    I have been taking nattokinase, vitamin E, cayenne and gingko biloba and the blood is fine. I finally had to get ablation to get rid of the A-fibs and tachycardia. My family Dr. did IV chelation therapy for the “widow maker” artery that got damaged. It is still fine eight years later.

  9. https://www.google.com/accounts/o8/id?id=AItOawmCHJhd70X5rmw43XQt25H8QyF7b_nZ9JM
    Reply

    My husband was diagnosed with A Fib at 90 when he was in very good health despite surviving two cancer episodes. The cardiologist put him on Pradaxa and within two months he hemorrhaged severely and required blood to restore him to normal levels. They found no reason for the hemorrhage. Three months later, they put him back on Pradaxa and, yes, the same hemorrhage–worse this time. There was no sign of bruising or any of the warnings posted above. Just a sudden episode of diarrhea.
    I would add a warning sign of my own: when the person being treated becomes pale and fatigues more easily, it is a sign to get a blood test quickly. We had attributed it to “old age.” Every time we think old age is going on, so far, we discover that the incipient frailty has a direct and treatable cause. No more blood thinner for us. Just baby aspirin. He will be 93 in May, still doing chores, working, driving. Blessed.

  10. DF
    Reply

    Have your drs review MTHFR and other genetic variants that a naturapath can help with.

  11. ladygray4
    Reply

    I was put on Pradaxa + aspirin for stroke prevention for Afib. After a couple of weeks, I was concerned about bruises that appeared out of nowhere, but the cardiologist’s office just brushed it off as “just something I’d have to deal with.” Guess I’m strange for not wanting to walk around looking like I got beat up daily.
    And this was AFTER the cardiologist gave me a choice of which treatment option to choose; after I chose, she tried to guilt me into another one – then WHY did you give me a choice?
    I was 58 years old when I started going to her; she talked down to me as if I were 88.
    I no longer go to that quack!!!

  12. J.L.
    Reply

    I am on warfarin. I have a home monitor. I am lucky enough to be covered by insurance as the monitor and the testing strips are costly. Research has shown that more frequent testing generates more time in appropriate testing-range (fewer strokes, fewer hemorrhages). The research also encourages patients to home-test once a week. I test, on average, every ten days. I am rarely more than 0.2 out of range. I adjust my dose myself when need, which is very rare.
    Some doctors would rather not have the patient adjust their own dose. My doctor is okay with it. I report my INR via a telephone call to an automated system. The company then reports the result to the doctor. It takes 5 minutes. No drive to the lab. No venous blood draw; it’s just a quick finger stick. And in-range for long periods of time. (P.S. Patients get training with the device. It takes a little time to become proficient in its use.)

  13. GH
    Reply

    My husband switched from Coumadin to Pradaxa because he was tired of the continual blood withdrawal to test for coagulation with the coumadin. Although he was 84, his doctors did not prevent him from switching. After 4 months on this new drug, he had a stroke and died. This surely does not prevent strokes without being monitored. The artery leading into the heart from below, was so clogged up the doctors could not open it up.
    I certainly would not recommend this as a treatment for atrial fibrillation, which he had.

  14. MSS
    Reply

    Ten years ago I suffered a severe year-long episode of anal bleeding and itching (pruritis ani). Symptoms abated when we bought a new clothes washer and changed our laundry detergent. However, my anal area remained sensitive to irritants, especially acidic foods. I recently was diagnosed with atrial flutter, and was I prescribed Pradaxa as a blood thinner. Within a month I had anal itching and bleeding worse than I had ever had before. I gave my cardiologist the choice of letting me quit Pradaxa cold or letting me taper off. He had me taper off over 4 days. Within 2 weeks the symptoms were gone.

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