Must-read: marketing vs. medicine in the case of Pradaxa (dabigatran)

4 out of 5 stars Dabigatran: how the drug company withheld important analyses. Cohen D. BMJ 2014 Jul 23;349:g4670. doi: 10.1136/bmj.g4670. Full Text As TPR has reported before, there has long been reason to doubt the claim that the anticoagulant dabigatran (Pradaxa) can be safely and effectively used for prevention of strokes in patients with non-valvular atrial fibrillation without laboratory monitoring. This must-read investigative report uses internal company documents released in association with a lawsuit — recently settled for $650 million — to suggest that Boehringer Ingelheim, the drug’s manufacturer, suppressed evidence that using a laboratory test to adjust dosing could reduce the incidence of major bleeds associated with the drug. As the BMJ report points out, the claim that monitoring levels and/or anticoagulation effect was not necessary when using Pradaxa was a key talking point in marketing the drug. However, a company study had determined that blood levels of dabigatran were unpredictable, varying five-fold from patient to patient. One cardiologist who advised the FDA noted: “I’m struck by what my eyeball tells me about a five-fold variability [in plasma levels] within the 90% confidence [interval] of the 150-dose. That seems awfully big to me in a drug that we’re proposing to use without therapeutic monitoring.” This unpredictability was especially important because there was no available and effective way to reverse the an...
Source: The Poison Review - Category: Toxicology Authors: Tags: Medical adverse drug event anticoagulant bleeding boehringer ingelheim dabigatran hemorrhage pradaxa Source Type: news