PRADAXA® is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. PRADAXA lowers the chance of blood clots forming in your body.1
This drug is not approved for any other issues; including Antiphospholipid Antibody Syndrome.2
After interviewing Craig Cole, MD, Hematologist at Gundersen Lutheran Medical Center. I am surprised it was it was approved by the FDA. While the marketing & prescribing information do not say much, the grey information is starting to come out and was discussed at the recent American Society of Hematologists (ASH) meeting, which the APSFA was invited to attend.
After having many problems keeping my INR regulated, I thought Pradaxa® was going to be my answer. I am tired of weekly plus INR draws – the whole nine yards. Initially, my big concern was there is no way to reverse it.2 There is still no way to reverse it. “While the prescribing information states there are things the doctors can try, they do not work. This is being found out in after market research and was discussed at the recent ASH meeting,” according to Dr. Cole.
During our discussion there were many more new things that I have learned about the “grey area” that is being reported in after market effects and were discussed at the ASH meeting. According to Dr. Cole:
This drug has an extremely short half life, meaning if you are two hours late taking it, you are risking a clotting event. Pradaxa® causes stomach issues2 but you can not take anything for the stomach issues (no Tums, no Proton Pump Inhibitors, nothing) as it will not let the Pradaxa® absorb, and you will risk a clotting event. If you have problems with your metabolism being too fast or too slow, this can cause problems. Too fast, you risk a clot, to slow you risk a bleed. Pradaxa® actually has a higher risk of drug failure than warfarin does. Yes, I said higher. Again, I will stress there is no way to reverse Pradaxa®.2If you have kidney issues or kidney failure and start bleeding through them, as that is the way Pradaxa® is excreted, you are probably looking at death. No, dialysis will not work as Pradaxa® is too small and passes through the dialysis filters. The Pradaxa® just will never leave your system. This is why Boehringer Ingelheim has these disclaimers on their website regarding kidney issues.1The company, Boehringer Ingelheim, claims they are trying to make a drug to reverse it but ASH and Dr. Cole have yet to any papers or studies regarding this. There is no way to monitor Pradaxa®. I am sure you are saying, but it is weight based, no not really. It is set up as a one dose fits all and a separate dose for those who have kidney issues.2 They do not have any way to see what your blood levels are at all. As an example, Lovenox® can be monitored by an Anti-Xa or aPTT.3 If you start clotting on Pradaxa®, they have no way to know if you are getting enough Pradaxa® and it doesn’t effect any current tests that are used. Your blood will look “normal”.
According to Dr. Cole, the reason this drug is only used for atrial fibrillation patients is this, “you can stop someone’s warfarin with Atrial Fibrillation and it will take almost five years for them to clot. They can have the smallest amount of this drug and probably be ok. However, those with clotting disorders to not have that luxury.”
Rebecca Craft Stroud, a member of our APSFA Fan Page, says “Beware of Pradaxa®! My mother is dying in the hospital from bleeding caused from this potent drug. Do your research, and do it thoroughly. Don’t be misled by the promises of convenience and the “miracle medical advances” the drug claims to offer.”4
After hearing this there will be no way I will taking Pradaxa® and if you are currently taking Pradaxa® please discuss these topics with your prescribing doctor. There should be a new and better one on the market in five years that will probably replace Pradaxa®. Dr. Cole did say there is hope that we will have something better than warfarin in the future but this isn’t the drug for us.
Sources:
1. PRADAXA® Official Site. Available at: http://tinyurl.com/3q5pcnt. Last Accessed: October 22, 2011.
2. HIGHLIGHTS OF PRESCRIBING INFORMATION. Available at: http://tinyurl.com/66o9j8p . Last Accessed: October 22, 2011.
3. HIGHLIGHTS OF PRESCRIBING INFORMATION. Available at: http://products.sanofi.us/lovenox/lovenox.pdf. Last Accessed: October 22, 2011.
4. APS Foundation of America, Inc Facebook Fan Page. Available at: http://www.facebook.com/APSFA. Last Accessed: October 22, 2011.