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Boehringer Ingelheim withheld safety analyses on new anticoagulant, The BMJ investigation finds

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g4756 (Published 24 July 2014) Cite this as: BMJ 2014;349:g4756
  1. Zosia Kmietowicz
  1. 1The BMJ

The drug company Boehringer Ingelheim withheld from doctors and drug regulators the fact that monitoring the blood level of its new anticoagulant stroke drug and adjusting the dose could substantially reduce major bleeds associated with it, an investigation by The BMJ has found.1

Dabigatran (marketed as Pradaxa) was licensed for stroke prevention in patients with non-valvular atrial fibrillation by the US Food and Drug Administration in 2010 and by the European Medicines Agency a year later. It is one of a new generation of oral anticoagulants that have been marketed as being more convenient than the traditional anticoagulant warfarin because patients do not need regular tests to check concentrations of drug in their blood.

This unique selling point has been used prominently by Boehringer Ingelheim. Dabigatran did not require “regular blood tests to …

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