Risk of Potentially Fatal Serious Bleeding Events with Anticoagulants Including Pradaxa

The 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, the FDA received a large number of post-marketing reports of bleeding among Pradaxa users. As a result, the 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. The results 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 FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.


The FDA believes that a simple comparison between Pradaxa and warfarin with respect to the numbers of post-marketing reports of bleeding in the AERS database is misleading because bleeding events associated with warfarin (a well-recognized consequence of warfarin use, which has been available for many years) are likely underreported compared to events occurring with the more recently available Pradaxa.


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.


The 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.


As part of its ongoing safety review of Pradaxa, the FDA is conducting two additional protocol-based observational assessments. In addition, the FDA continues to monitor post-market reports for evidence of inappropriate dosing, use of interacting drugs, and other clinical factors that might lead to a bleeding event. 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.


See the FDA Drug Safety Communication