3 April 2015 (Friday) - Dabigatran


BARNES, HEDWARD                                      06:38
MR      20/08/1940   Male   654321            Emergency Care Centre
185 Eaton Place                   Dr Foley
Specimen No : AK564330X    Haematology & Chemistry        

03/04/2015 06:38  Citrated Blood
 Request Reason :     chest pain

 PT                        20.4   s         (    12 to 16    ) Auth
 APTT                      51.3   s         (  22.0 to 35    ) Auth
 APTT Ratio                ^1.8                                Auth
 I.N.R.                     1.4                                Auth

  Coag Screen

  LTG Comments :
    Patient is on dabigatran
  

Dabigatran (Pradaxa or Prazaxa) is an oral anticoagulant acting as a direct thrombin inhibitor. It is being trialled for various clinical indications and is claimed to offer an alternative to warfarin as the preferred orally administered anticoagulant since it does not require INR monitoring while offering similar results in terms of efficacy.

There is no specific way to reverse the anticoagulant effect of dabigatran in the event of a major bleeding event unlike warfarin although a potential dabigatran antidote (pINN: idarucizumab) is undergoing clinical studies.

It was developed by the pharmaceutical company Boehringer Ingelheim… on July 26, 2014, the British Medical Journal (BMJ) published a series of investigations that accused Boehringer of withholding critical information about the need for monitoring to protect patients from severe bleeding, particularly in the elderly.
Reviews of internal communications between Boehringer researchers and employees, the FDA and the EMA revealed that Boehringer researchers found evidence that serum levels of dabigatran vary widely. The BMJ investigation suggested that Boehringer had a financial motive to withhold this concern from regulatory health agencies because the data conflicted with their extensive marketing of dabigatran as an anticoagulant that does not require monitoring.

I can’t help but wonder how many other “wonder drugs” aren’t quite so wonderful. Perhaps if they weren’t quite so lucrative…? 



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