The Food and Drug Administration (FDA) announced it has evaluated new information about the risk of serious bleeding associated with use of the blood thinners dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics), and determined that bleeding rates with Pradaxa do not appear to be higher than bleeding rates with warfarin, despite the high number of adverse event reports the agency has received about Pradaxa. The FDA, however, says it is continuing to evaluate multiple sources of data in the ongoing safety review of this issue.
Pradaxa was approved in 2010 to prevent strokes in patients with a heart condition called atrial fibrillation. Following 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 assessment was done using insurance claims and administrative data from the FDA’s Mini-Sentinel pilot of the Sentinel Initiative. A s a result of this assessment, the FDA believes that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.
The FDA has not changed its recommendations for Pradaxa, but did say that health care professionals who prescribe the drug should carefully follow the dosing recommendations in the drug label, especially for patients with renal (kidney) impairment to reduce the risk of bleeding.
The agency says it will continue to review data on Pradaxa and bleeding events. As part of an ongoing safety review of the blood thinner, the FDA is also conducting two planned, protocol-based observational assessments that 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.