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Pradaxa Measurement: An Oxymoron?

George sent this message to Dr. David AlterSpectrum Health System, Grand Rapids, Michigan (once named Butterworth Hospital), regarding a question he posted on MEDLAB-L on Monday, June 10, asking, “Isn’t monitoring Pradaxa an oxymoron?”:

“Hi, Dr. Alter. I subscribe to MEDLAB-L and just saw your post regarding Pradaxa measurement. May I post your question and some discussion of new oral anticoagulant measurement on my web site, The Fritsma Factor? By the way, I’m a graduate of the old Butterworth School of Medical Technology, back when the earth was still cooling.”

On Tuesday, Dr. Alter wrote, “It would be my pleasure. Isn’t it an oxymoron? Not the clotter at my institution but I am the blood banker and do worry about what to do when we get the inevitable Pradaxa bleed as I have already seen with the LMW heparin bleeds.”

Dr. Alter’s comment came just a few days after Kim Kinney’s (IU Health) June 5 post, “Measuring Dabi and Riva.” In that post I appended the Europace 2013 article,Heidbuchel H, Verhamme P, Alings M, et al: European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013; 15, 625–51, which provides the indications, dosages, and available assays for dabigatran, rivaroxaban, apixiban, and the soon to arrive edoxaban, and which I recommend to everyone confronted with managing the new oral anticoagulants in the real world, of “polypathology.”

Attached to Kim Kinney’s post is a summary of new oral anticoagulant measurement by regular contributor Dave McGlasson, researcher at Wilford Hall USAF Medical Center at Lackland AB in San Antonio, who is wrapping up the data-gathering phase of a large trial comparing the currently available assays for dabigatran. See also Dave’s June 11 post, “Rx Level for Dabi?“. In follow-up to his post asking for information on therapeutic target levels, I contacted Dr. Hein Heidbuchel, MD Department of Cardiovascular Medicine University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium, lead author of the European Heart Association publication. Dr. Heidbuckel responded that his group had no further information beyond what is published in the article.

Judging by expressions from Ms. Kinney, Mr. McGlasson, Dr. Alter, and the publication of Dr. Heidbuchel, we can’t overstate the level of concern for the laboratory management of the new oral anticoagulants, all released with the statement that they require no laboratory monitoring. For lab scientists in the US, please  keep in mind that as I posted June 11, What is an RUO/IUO?, the FDA has yet to clear any of the new assays.

Comments (1)
Anticoagulant Therapy
Aug 19, 2013 2:33pm

i would like to point out that Pradaxa and the new direct Xa
i would like to point out that Pradaxa and the new direct Xa anticoagulants are all oral. why does anyone think that people are NOT going to overdose on these drugs? people have been overdosing their coumadin for 50 years. There are other things to be taken into consideration when dosing with these drugs, i.e. memory.

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