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FDA Date: 11/2/12
Pradaxa (dabigatran etexilate mesylate) FDA Drug Safety Communication
Update on the risk for serious bleeding events with the anticoagulant Pradaxa This update is a follow-up to the FDA Drug Safety Communication of 12/7/2011: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate)
The U.S. Food and Drug Administration (FDA) has evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). Following the approval of Pradaxa, FDA received a large number of post-marketing reports of bleeding among Pradaxa users. As a result, FDA investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) for new users of Pradaxa compared to new users of warfarin. This assessment was done using insurance claims and administrative data from FDA's Mini-Sentinel pilot of the Sentinel Initiative. The results of this Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.
Pradaxa and warfarin are important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common heart rhythm abnormality, which causes the heart (upper chambers or atria) to beat rapidly and irregularly. Although these drugs reduce the number of strokes in patients with non-valvular AF, they can cause bleeding, potentially leading to serious or even fatal outcomes. The risk of bleeding is a well-recognized risk of anticoagulant drugs.
FDA has not changed its recommendations regarding Pradaxa. Pradaxa provides an important health benefit when used as directed. Healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment (when kidneys don't function normally) to reduce the risk of bleeding. Patients with atrial fibrillation should not stop taking Pradaxa without first talking to their healthcare professional. Stopping use of anticoagulant medications such as Pradaxa can increase the risk of stroke. Strokes can lead to permanent disability and death.
Mini-Sentinel is a pilot project of the Sentinel Initiative. The Sentinel Initiative is sponsored by FDA to create an active surveillance system using pre-existing electronic healthcare data from multiple sources to assess the safety of approved drugs and other medical products.
As part of an ongoing safety review of Pradaxa, FDA is also conducting two planned, protocol-based observational assessments which will assess patients taking Pradaxa and evaluate bleeding events. The agency will continue to communicate to health professionals and the public any relevant information that becomes available on the risk of bleeding and Pradaxa.