So, do we congratulate this firm or excoriate them?  What am I talking about?   Boehringer Ingelheim (B-I) and what it just did about its blockbuster drug, Pradaxa.

I wrote about this new drug a few years ago.  It is an alternative to coumaden, a fancy name for warfarin- the rat poison.  Coumaden has been a staple regimen for patients with artificial heart valves, those who suffered strokes, etc.

The “drug” is taken to insure that the patient’s blood does not clot.  And, given the fact that it really is rat poison, it means that frequent blood clotting tests must be run. If you are a male taking the drug, then, to some degree, the dosage is pretty stable.  But, you can still be taking too much or too little.  Hence, the routine blood tests.

But, if you are female- and of child-bearing age- then the dosage requirements vary all over the map.  Because menstruation really screws up the amount needed.  So, you can be over- or under-medicated all the time.

You also must avoid cruciferous vegetables, since their clotting capabilities interfere with the ability of coumaden to stop blood clots from forming.  Which is one of the primary reasons that the alternative drugs rivaroxaban, dabigitran, and apixaban were developed.

Dabigatran was the first of the three approved and has been marketed as Pradaxa (by B-I).  And,while it was the first approved, it turns out it may only be marginally better than coumaden.  (There is a major lawsuit pending against the drug filed in Chicago.)   Pradaxa is used by some 850,000 patients and has accumulated some $ 2 billion in sales.  But, it also is linked to more than 1000 patient deaths.

And, B-I’s Director of Clinical Development and Biostatistics (Dr. Paul Reilly) has just published a paper along with researchers at Jefferson Medical College and Uppsala Clinical Research (among others) that recommends that routine blood tests be performed by those taking Pradaxa in certain circumstances.  Which certainly ticked off (I am being understated here) many of the marketing professionals at B-I; after all, the primary advantage claimed by Pradaxa is that you don’t need the routine blood testing required by those taking the alternative drug, coumaden.

(Dr. Jutta Heinrich-Nols of BI is cited in the court documents that this report would obviate B-I’s competitive advantage (that blood testing is not required with the drug).  It would lose the race to Xarelto [rivaroxaban] and  Eliquis [apixoban].)

It turns out that not everyone metabolizes Pradaxa in the same way.  Especially older patients.  It should be noted that while coumaden is proffered for a variety of conditions, Pradaxa is specifically approved for use in patients with atrial fibrillation.  And, some patients absorb too little of it to preclude strokes, while others metabolize so much of it that they are subject to excessive bleeding.  (Remember, these drugs are used to stop blood from clotting; if blood doesn’t clot, then a little cut can become a big bleed.)

But, the paper WAS published.  Drs. Reilly, T. Lehr, S. Haertter, S. Connolly, S. Yusuf, M. Ezekowitz, G. Hehmiz, S. Wang, L. Walltenin, and Mr. J Eikelbloom presented the data.  But the optimum level of the drug was not published.  (It was in the original submitted paper.) So, those whose metabolism puts them outside of that range need testing need to do more digging.

It should be noted that in the US folks take a 150 mg dose, unless they have kidney problems who then take a 75 mg dose.  But, in Europe, there is also a 110 mg dose that may turn out to be the best solution for these outlier patients.

Oh, there’s one more piece of information.  Coumaden (warfarin) and Pradaxa are the top two reported anti-coagulant drugs to the FDA. (That means they pose significant problems.)

Advantage Eliquis and Xarelto?   Or, do you think this publication will help Pradaxa regain credibility?

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