New York Times on dabigatran

November 4, 2012, 12:48 am

The New York Times today ran an article under the headline “A Promising Drug with a Flaw“. The drug is dabigatran, used to prevent stroke in patients with non-valvular atrial fibrillation. The flaw is that when a patient anti-coagulated on dabigatran comes in with significant intracranial or gastrointestinal hemorrhage, there is no antidote that will reverse the effects of the drug.

The Times reports that 542 deaths in the U.S. have been associated with use of dabigatran during the year 2011, and that the drug was “linked to more reports of injury or death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices“.Although the manufacturer claims that Pradaxa has a “favorable benefit-risk profile . . . when used correctly according to the approved label”. What the article does not stress strongly enough, in my opinion, is that the package insert for Pradaxa states that dosing should be based on creatinine clearance (CrCl). Since dabigatran is eliminated by the kidney, renal dysfunction may cause increased drug level. In fact, the RE-LY trial, the major study evaluating use of dabigatran, excluded patients with CrCl < 30 ml per minute. It is unlikely that many patients started on dabigatran have had their renal function fully evaluated.

The Times piece also notes that the manufacturer — Boehringer Ingelheim — recommends treating dabigatran-associated hemorrhage with hemodialysis to enhance elimination of the drug, but points out that recommendation might not be realistic. In fact, I am not aware of any cases where that recommendation was carried out successfully.

External reference: FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (Nov 2, 2012)

Related posts:

Case series: four patients with dabigatran-associated bleeding

Guidelines for reversing overdose of dabigatran (Pradaxa) and other new anticoagulants

Care Report: fatal GI bleed 6 days after one dose of dabigatran (Pradaxa)

Dabigatran: is laboratory monitoring really unnecessary?

Dabiagtran and the trauma patient

Dabigatran Toxicity: The Top 10 Questions

Review: the bleeding patient on dabigatran

Dabigatran and the elderly

Dabigatran etexilate: a new challenge for emergency physicians and toxicologists


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