The Poison Review

Dabigatran: Uncharted Waters and Potential Harms. Radecki RP. Ann Intern Med 2012;157:66-68.

No abstract available

The Institute for Safe Medication Practices has reported that soon after its approval in October 2010,  the oral direct thrombin inhibitor dabigatran etexilate (Pradaxa) was associated with a higher incidence of adverse events than almost any other drug.

In this opinion piece, Ryan Radecki — curator and author  of the essential blog Emergency Medicine Literature of Note — reviews some of the factors contributing to this alarming alarming association:

• Dabigatran etexilate is available in the United Sates in doses of 75 and 150 mg, and it is unclear which dose is safer and/or more effective.
• Drug interactions — including those with proton-pump inhibitors, amiodarone, and verapamil — complicate dosing.
• There is no readily available laboratory test that can be used to monitor patients on dabigatran.
• In cases of dabigatran-associated bleeding, there is no antidote effective in reversing the anticoagulant effect.
• The drug is often prescribed for off-label uses.
• Unanticipated adverse events — such as increased relative risk for myocardial infarction or acute coronary syndrome — have been discovered after dabigatran came on the market.

This short review is well worth reading. In a recent letter to the Annals of Internal Medicine, Patricio Pazmiño points out that the largest study to date of dabigatran — the RE-LY Trial — excluded patients with creatinine clearances < 30 ml/1.73 m³,  a laboratory value that is rarely measured clinically. Since dabigtran is eliminated through the kidneys and is often used in the elderly who may have covert renal insufficiency, frequent complications can be anticipated.

Related posts:

New York times on dabigatran

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