Dabigatran etexilate mesylate (Pradaxa) - Ongoing Safety Review
November 5, 2012
FDA released new information about the risk of bleeding with dabigatran etexilate mesylate (Pradaxa®). In December 2011, FDA alerted healthcare professionals and consumers of an investigation of post-marketing reports of serious bleeding events associated with dabigatran etexilate mesylate. Dabigatran already carries a warning of significant and possibly fatal bleeding. Major bleeding events occurred in a similar number of patients receiving warfarin and dabigatran in a clinical trial of 18,000 patients. FDA has been investigating whether the frequency of bleeding events reported with dabigatran since its approval is greater than the frequency observed in the clinical trial.
Based on FDA’s analysis, the risk of serious bleeding events is not higher with dabigatran than with warfarin. FDA evaluated the rates of intracranial hemorrhage and gastrointestinal hemorrhage with dabigatran or warfarin, based on data in their Mini-Sentinel database, from October 19, 2010 (date of dabigatran FDA approval) through December 31, 2011. Compared with new dabigatran users, new warfarin users were 1.8 – 2.6 times more likely to experience either event, 1.6 – 2.2 times more likely to experience gastrointestinal hemorrhage, and 2.1 – 3 times more likely to experience intracranial hemorrhage. FDA is continuing to evaluate data regarding bleeding risk with dabigatran.
Dabigatran is an anticoagulant labeled for use in patients with non-valvular atrial fibrillation, to reduce the risk of stroke.
Educate patients not to stop dabigatran without consulting a healthcare provider, and to tell their healthcare provider if they experience bleeding events such as red or black stools or coughing up blood. Healthcare professionals should follow the drug label recommendations to ensure proper use of dabigatran and to minimize the risk of bleeding events, especially in patients with renal dysfunction.
Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication, November 2012:
- Drug Safety Communication, December 2011:
November 5, 2012. University of Utah Drug Information Service. Copyright 2012, Drug Information Service, Universtiy of Utah, Salt Lake City, Utah.