Follow-up Blog: Important questions and answers on Pradaxa

This post was authored by Brian Nash and posted to The Eye Opener on January 10th, 2011.

Share |

 

Subscribe via Email!

 

Subscribe to this blog via Feedblitz RSS

Some months ago, we published a blog to announce what we thought was important medical news about a new product called Pradaxa. That blog, entitled A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?, was widely viewed by many readers since October, 2010. Following our posting, a number of those readers have sent us questions about this new drug. To better serve our readers, we have invited Dr. Steven M. Davis to be our guest blogger on Pradaxa, and to answer some of these important questions.

Dr. Davis is the Associate Professor of Pharmacy at the Campbell University College of Pharmacy and Health Sciences in Buies Creek, NC. He is also the Clinical Coordinator for Pharmacy Services at Wake Forest University Baptist Medical Center in Winston Salem, NC. Dr. Davis has a PharmD with a specialty certification in geriatric pharmacology.

Below are the most frequently asked reader questions:

  1. How does Pradaxa differ chemically to Coumadin (Warfarin)?
  2. Do things with high Vitamin K (like spinach, lettuces, and broccoli) interfere with Pradaxa?
  3. If one were to start Pradaxa, how long would it take the blood to thin? If one were already taking Coumadin (Warfarin), what is the recommended method of switching to Pradaxa?
  4. How long would it take to reverse the effects of Pradaxa? I have been told Coumadin (Warfarin) stays in the body and before any surgery a patient has to wait 5 days.
  5. Why doesn’t the blood coagulation need monitoring if Pradaxa thins out the blood? Why wouldn’t the blood protime (PT) need monitoring with Pradaxa?
  6. How would someone adjust Pradaxa to keep the protime (PT) at a desired level?
  7. Are there any restrictions to other medications such as Aspirin?

Dr. Davis’ responses are listed below:

Question 1: Pradaxa (Darbigatran) is a direct thrombin inhibitor.  Thrombin is one of many clotting factors in the body necessary for coagulating blood.  Coumadin (Warfarin) works by a completely different mechanism. Coumadin/Wafarin prevents the activation of 4 clotting factors that depend on Vitamin K .

Question 2: Since Pradaxa works by directly inhibiting the clotting factor thrombin, the amount of vitamin K in the diet does not matter.

Question 3: When switching from Coumadin to Pradaxa, a physician will usually wait for a patient’s INR to drop below 2 before starting Pradaxa.  In most patients taking Pradaxa, blood will be appropriately thinned 2 to 3 days after starting the medication.

Question 4: Pradaxa is still a blood thinner and care must be used before surgery.  Pradaxa has a shorter life in the body (that is why it is dosed twice daily) and it is cleared from the body quicker than Coumadin (Warfarin).  It is recommended that a patient discontinue Pradaxa 1-2 days before surgery if they have normal kidney function and 3-5 days if they have impaired kidney function.  Of course you would NEVER stop this medication without consulting your physician first.

Question 5: Prothrombin time (PT) and INR measure the ability of Coumadin (Warfarin) to prevent the activation of the Vitamin K dependant clotting factors.  Again, since Pradaxa does not affect these factors, the prothrombin time does not change and, therefore, does not need to be monitored.

Question 6: The biggest advantage to Pradaxa is that there are fewer drug interactions, less food/drug interactions (Vit K containing foods), and thus no need to monitor prothrombin time or INR.

Question 7: Combining Pradaxa with aspirin will increase a patient’s risk of bleeding.  Both medications are used together frequently but ONLY under the direction of a physician.

Dr. Davis offers the following advice to patients considering taking or taking the drug Pradaxa.

This is a new medication and as with all new medications, it has not been used in a large population of patients yet.  New side effects and drug interactions may be discovered as this drug is used more frequently.  The Food and Drug Administration (FDA) monitors these reports and will issue statements as necessary.

From Brian Nash: I want to take this opportunity to thank Dr. Steven Davis for providing us with this information for our readers.

To our readers: Please keep in mind that we, at Nash & Associates, are not physicians. While Dr. Davis was so kind to provide the information he did regarding Pradaxa, this is not the usual approach we would take to our blog postings. From time to time we try to make you aware of important and/or interesting medical news. However, if you have questions about Pradaxa, we strongly urge you to speak with your personal physician.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Tags: , , , ,

Share |

Subscribe To The Eye Opener via Email!


Just enter your email address below and you'll get a daily digest of our blog postings - for free!

 

Other Ways To Connect


You can also connect with us via RSS, our Facebook page, our Twitter Page, or our LinkedIn page.

34 Responses to “Follow-up Blog: Important questions and answers on Pradaxa”

  1. TheresaNo Gravatar says:

    This is excellent information for anyone on blood thinners. I like the fact that you asked a Doctor of Pharmacology to answer some of the questions posed by readers! And yes, patients should always discuss any information that they obtain over the internet with their primary or specialty physicians! Sometimes, the physician actually learns something from the patient!

  2. Gary MillerNo Gravatar says:

    What is the dosage for patients taking coumadin to achieve 1.5 – 2.0 NIH levels for mechanical heart valves? Would this drug be considered for administration post open heart surgery for initial 30 days? Possibly avoiding A-FIB complications?

  3. shadmanNo Gravatar says:

    please short briefe concentrated info about the pradaxa and mechanisim, side effects , adverse effects , interactions….etc for caregivers
    respectively

  4. Was. put on 150mg,twice a day.On second day unable to get warm with 4 blankets,2nd day ankle turned cherry red apparently from my socks ,on third day bled from nose and lungs for over 16 hrs. THERE must be a way to alter dosage or to moniter dosage levels

  5. My Grandmother 90, was swithed from metapopyl or something like that to Sotalol and in addition Pradaxa, She began a spiral downward , tired, nosebleeds, diarehea (black) blood pressure dropped, heart went rapid, she was so weak I took her into emergency and they said She needed blood ! and 4 pints of it too! and shes 102 lbs!!!!! I heard the Dr at the Hospital, a hospitalist, who said she was his 1st patient he had seen with this drug, and the 1st who had been overdosed in effect too! He was not sure if the bleeding an even be stopped!
    She was 4 days in Intensive care unit! and is still in the hospital now. A gastroenterologist suspects an old uler was made to hemmorage and if she had anything weak it would bleed! They all seemed to be saying BIG MISTAKE! the Cardiologist who gave it to her was embarassed. She was almost killed and i dont know She isnt permanently affeted by this! Do not take this stuff!

  6. TheresaNo Gravatar says:

    The FDA has an adverse event reporting system for both health professionals and consumers. The adverse events should be reported. Click the following link: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm or cut and paste into your browser.
    As Dr. Davis clearly stated, although this drug is approved for consumer use through prescription, it is still very new. As more patients are treated with the drug, more potential side effects and adverse reactions will come to light, and the FDA will have to review the safety and efficacy of the drug. In order for this to happen, patients and providers MUST report such events! Please take the time to do so as a public service!

  7. Fred HarmanNo Gravatar says:

    Since you state that planned surgery requires that Pradaxa be discontinued for 2-3 days what can be done if you have an accident and have a severe cut that doesn’t stop bleeding. What is there to thicken the blood so surgery, etc. can be done? (vitamin K has no effect on Pradaxa!!!) No one seems to have an answer to this!

  8. TinaNo Gravatar says:

    I am a 41 Yr old woman–I was currently put on Pradaxa … I ve only been on it since April 14th no side effects so far i take it twice daily 150mg . Plavix was what i was on before and my body was not absorbing it or however u might say and i had 2 strokes while on it .. ( thank God i also felt like i should take an asprin and even though not advised i took a 325 asprin almost daily) probabley saved me.. Pradaxa works so much differently then Plavix and Coumadin…I like all my greens and taking your pro time 8 – 10 times month did not work for me , i dont drive and i have three children, 22, 17, and 12..also two grandbabies.. I have alot to live for i pray this is the “wonder drug”…

  9. Update:
    My 90 yr old Grandmother is still bleeding, there is no counteractant, She has been back to intensivew care another 4 days and 2 more transfusions. Her life has been irreperably compromised, she cannot walk unassisted and is dizzy, weak, tired, still bleeding from unknown areas, Docs said risk outweighs benefit regardless of whether endoscopy reveals where its from treatment remains same, transfusions, that is the treatment, there is nothing to stop it. She was not adequately informed until far after almost dying from it, a 90 yr old should never take this or certainly not at home alone!!

  10. markNo Gravatar says:

    Keith,
    your grandmother is 90 years old! People do not live for ever. There are risks with any drug. She was probably put on pradaxa due to stroke prevention for her atrial fibrillation. If she wasn’t put on pradaxa she would be at high risk for having a stroke. Perhaps you shouldn’t be blaming the cardiologist or the drug. Her life has been irreperably compromised by being 90.

  11. MildredNo Gravatar says:

    I have had to off warfarin before back surgery and a bone marrow. I have had two TIA’s from the situation.
    Does Pardaxa prevent this from happeinin?

  12. Mildred,
    Pradaxa is a type of blood thinner that prevents the blood from clotting. If the TIAs are related to blood clots forming, then Pradaxa should prevent these. If the TIAs are related to some other phenomenon, then not necessarily. Pradaxa’s effect is similar to Coumadin, but if you read the blogs, it’s mechanism and management are different. You will need to speak to your doctor about this drug to see if it could potentially help you.

  13. I started Pradaxa April 29, 2011. I had one terrible burning in upper digestive tract apprx 1 1/2 wks after. I lost 5 pounds in firt week. Now I feel, often, that I have overeaten even when I haven’t eaten anything. I have a Pacemaker and A-Fib. My main problem is extreme weakness whenever standing. I also have failed Pituitary, Adrenal and Thyroid glands. These glands failed about 4 years ago, 1 year after Pacemaker was implanted. For this I must take steroids. Is there anyone out there in this situation – failed Pituitary and also A-Fib and Pacemaker? I am desperate.

  14. SLSWNo Gravatar says:

    This reply is 2 fold, I cannot believe anyone would be so insensative to make remarks like Mark did. Also My family member lost his life to pradaxa he was 51, was that because he was 51, we did not want him to live forever, but 35-40 more years would have been ok with us! This is a bad drug, no reversal, He had a intercrainial bleed very small at first but due to inability to reverse, the bleed ended up terminal. To Keith, I hope your grandmother recovers.

  15. My huaband was in a automobile accident recently and broke his hip and all his ribs on the left side. Because he was taking Pradaxa he had to have a dialysis treatment to get rid of the Pradaxa in his system before they could do surgery. The doctos waited 5 days before doing the dialysis and had to give him 9 units of blood because they could not stop the bleeding in his spine and could not do surgery to remove the spine due to his blood being to thin and not clotting. I think this drug should be looked at again by the FDA and taken off the market until further studies have been done. He will never take Pradaxa again because it is to dangerious.

  16. Again, I encourage everyone to report these events to the FDA medwatch program. See my previous comment and click the link or cut and paste into your browser! These kinds of reports are what will get the FDA to take another look at this drug’s risk profile!

  17. In February my Grandmother was given Pradaxa without the slightest mention of the drugs short time on the market, its lack of a counteractant, dangers of 75+ patients ever taking it,offered coumadin , which she had taken years ago! which is cheaper and has a protocol to counter drugs effect! She was given Sotalol and that alone suggests hospitalizationfor the 1st few days! and she was not on any thinners for 7 yrs and only mentioned the dizziness, which was nothing new or likely to be cured by Pradaxa! We called the 1st few days saying she feels terrible, almost too sick to get out of bed! which raised no alarms, she has now been hospitalized 2 times in intensive care, requires transfusions, which she never had before, is still dizy but bleeding now and no cure is existing to counter the drugs effects! Shrtly after her return home she did receive the information from the maker that was to be given prior to or at the time prescibed! She never would have chosen to be a guinea pig as she was tricked into, I have talked to several Doctors who said , it was insanity to give a 90 yr old pradaxa! They wopuld not take it nor give it to their Grandmother as well!
    The ER Dr had never even seen anyone taking Pradaxa that it was that new and was to be only given with full disclosure n ot after a hospitalization and 6 transfusions! She was a lively healthy ready to live to be 100 I would have bet! to a scaredf werak invalid who cant shop, go out, walk far, or enjoy her life at all except TV now! She should have never been given that drug and even if for some reason to justify it, should have been hospitalized for Sotalol and this drug Pradaxa! They sell it as safe and not requiring monitoring! FALSe nobody should pay more to get a drug with no counter agent!

  18. Joan KuikenNo Gravatar says:

    Is there a physicians compensation from the pharmaceutical company for prescribing Pradaxa? If so, how much?

    I plan to wait for it to be on the market for awhile before switching from coumadin. Far too often, a drug has been recalled by the FDA for life threatening reasons.

  19. Joan,

    Good question, but no. There is no physician compensation for prescribing any drug. There could be incentive if they own stock in drug company, though! This should never affect one’s judgment when prescribing a medication, but humans will be humans…….cannot say it never happens!

  20. JoanneNo Gravatar says:

    Great info. Will have hubby stay on Coumadon to see how this plays out in the long run.

  21. Hello, I am on this site elsewhere on another Pradaxa discussion, although mostly terrible side effects or deaths, not this pep rally for a dangerous drug that was used irresponsibly and without thought to My 90 yr old Grandmother. She had complained of dizzyness for years now and simply reiterated it at her cardiologists and he says we have this new drug and you wont need to be seen as with Coumadin you took 7 years ago, Well she was fine for 7 yrs, could go shopping, walk and wasnt bleeding for 6 months as now! The Sotalol She was given from metropolyl or similar named drug was why she was given this new drug, She wasnt warned/informed of just how new and just how few ad been given this drug Pradaxa, nore did she get the disclosure the drug mnfr mailed after she was back home from her 1st intensive care stay and 6 pints blood, soon another stay inintensive care and 2 pints blood 1 plasma, Ever since her strength is gone, her stools have blood and are dark, It was madness to give a 90 yr old Pradaxa and Sotalol , especially to say go home and do it and ignore our calls about how ill and weak she became until it was so bad I took her to the emergency room, and the hospitalist there was shocked they gave a 90 yr old a drug so new He had never sen it before now, and also never senen one overdosed on it either! He sdaid there is no remedy and we dont know if it will ever stop! He was talking DNR and that type of thing! She would have lived to be 100 I was quite sure! and now I am just as sure she will never make it to 100 , and if she does it will be a homebound weakened dependant existance. I have had several Drs say they would NEVER take this stuff and it is insanity to have given Sotalol and Pradaxa to a 90 yr old out of the hospital! They would not give it to their Grandmother as well! The idea that this stuff need not be monitered is a grave error!

  22. JanNo Gravatar says:

    In reference to the Pradaxa discussions, I unfornately lost my 84 yr old active mother, with only problem hypertension and perhaps beinning of Alzheimers but relatively in good health. Vistited a Cardiologist and according to diagnostic testing she had afib. Never complained about anything, visted Primary physician every 6 months for general evaluations. Cardio put her on PRADAXA 150 mg twice a day, along with 81 mg of aspirin. She was only on this medication for nearly one month and half and suffered a severe intracranial hemorrahage. The damage was so extensive that the Nerosurgeons were afraid to perform surgery and could not reverse the drug, neither promise to restore her neurological functions. ER Doctors were shocked to see this elderly patient on this lethal drug that apparently took her life. Please beware and carefully review all new medications and further ask questions to professionals. This drug should not be administered without checking the patients INR/ppt blood levels. BIG MISTAKE IT EVEN TOOK AWAY THE LIFE OF A 51 YEAR OLD MAN! I UNDERSTAND THERE IS NO PHYSICAN COMPENSATION, FDA NEEDS TO BAN THIS DRUG ACCORDINGLY. THANKS ,AND SORRY FOR YOUR LOSS AND DISCOMFORT.

  23. Update:
    Its been 7 months aprox and My Grandmother is no better as to the weakness and bruising with headaches she has never had before! Her life has been forever affected She cannot make it through a Wal mart and she did so easily for up to 4 hours at one time. Now reduced to being homebound tired and weakand blood is still being found in stool which also never had been before. This was a huge mistake and nobody but a few Drs will tell me this though not the one who was the proscriber!! This drug is way too expensive with no benefit to justify not using coumadin which vitamin K counteracts. There is nothing but transfusions or dialysis to try to remove it. I hear news and each week its not getting better!

  24. HypoGalNo Gravatar says:

    I am take lovenox twice a day. I have been waiting for this medication to arrive to market. I am going to see my doctor about making a change. However, I am hesitant because I don’t want to go backwards. I am warfin resistant and allergic to aspirin. I hope this ends up to be the medication that so many need. The cost of lovenox is extremely expensive.

  25. TinaNo Gravatar says:

    I havent posted a comment since April 28, 2011. I have been experiencing, dark stool, headaches, and have made an appt. with my Dr. to discuss this, also he requested lab work. I have taken it into my own hands to reduce my intake of Pradaxa to one time daily followed up by 81 mg aspirin before bed. I hate to Dr. myself, but i have gotten no real answers, if i can reduce dose or not…Does anyone know?, so i can please tell my Dr., before my appt. I have not felt good for months, i have been attributing it to stress and a recent bout with the flu…If anyone knows about the doses plz let me know, Thank You :)

  26. LindaNo Gravatar says:

    Please….anyone with advice….My 81 year old mother recently suffered a stroke. The first hospital she was admitted to, gave her coumadin a few days after the stroke to treat her afib that was just discovered. A day or so later, I asked the Dr. why my mom was so tired. She could barely stay awake and complained of a headache again. He decided to do a scan…..within an hour, my mom was flown to a stroke hospital because of a brain bleed. The coumadin was started too soon. She spent a month in the hospital. She is doing okay now….trouble talking and eating, but walking and seems much like her old self! Now the doctors want to start her on Pradaxa. (After one more scan to make sure brain bleed is healed.) I am really scared. She also suffered a brain anuyerism in 1994, but recovered. I tried talking to the doctor, but he seemed annoyed with all my questions. I am so worried about this bleed starting again. ……

  27. TheresaNo Gravatar says:

    Good morning, Linda. Keep in mind that we are a law firm and cannot provided specific medical advice. This sounds like a very difficult situation, but don’t be “bullied” or intimidated by physicians! In any case, it is imperative to get ALL of the information possible to make a good decision. This might mean consulting a Pharm D from the hospital and scheduling a meeting with the Pharm D, Cardiologist and yourself/mother; ask for such a meeting. If the Cardiologist is unwilling to make the time or accommodate you, then perhaps you need to find another cardiologist. These meetings are billable time, so there is no excuse for “waste of time”. A second opinion, and sometimes a third opinion, can be extremely helpful. Pharm D’s generally love to be consulted and provide input in their area of expertise; they are intelligent healthcare professionals who are under-utilized, and they can answer questions about the pharmocokinetics of any drug, often moreso than the prescriber. Please see my blog on second opinions….http://medicalmalpracticeblog.nashandassociates.com/2011/05/02/medical-second-opinions-an-under-utilized-option-for-patients/

    Theresa

  28. LindaNo Gravatar says:

    Thank you Theresa for answering my post. I honestly didn’t realize it was a law firm’s site. I was up late that night I left my post, reading several different sites with comments on Pradaxa. I found your site and the comments from your readers very helpful. But I must have been in a little bit of sleep mode lol. Anyway, thank you and I want to say that your advice about the meeting sounds really great.

  29. DeanNo Gravatar says:

    I almost died this month from Pradaxa. I bleed through the colon.

  30. BethNo Gravatar says:

    Can Pradaxa and Plavix be given together? My father’s was admitted for WPW. His cardiologist started him on both since he was poorly controlled on Plavix alone. What is the risk on being on both?

  31. hamada deifNo Gravatar says:

    looks fine one but what are theside effectsof pradaxa please let m know
    hamadA DEIF

  32. hamada deifNo Gravatar says:

    but what are its side effectcts

  33. hamada deifNo Gravatar says:

    hi what are the side effcts of praxada

  34. MourningNo Gravatar says:

    We believe my father died from this drug. After surgery, from which he recovered beautifully, he was started on Pradaxa before leaving the hospital. Left unattended, he fell and suffered a bruise to the hip. We, the family, we not informed of the fall and he was released from the hospital. Hours later he wound up back at the ER admitted to the ICU with what they believe was shock from internal bleeding. He had a huge internal hemmatoma and needed blood transfusions. He died a few days later.

    We are all in shock and in mourning. He survived his surgery so well and we were so optimistic for him thinking he added quality years to is life. I feel my father was stolen from us and died from unnecessary causes.

    Please, those who love and care for an elderly person, be warned of this drug. Anyone who might be prone to falling is in terrible danger in my opinion

Leave a Reply