Published On: Mon, Nov 5th, 2012

FDA evaluates the risk of serious bleeding associated with Pradaxa and warfarin

Pradaxa (dabigatran) and warfarin  (Coumadin, Jantoven, and generics) are important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation.

Image/National Cancer Institute

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. 

An 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 FDA believes that a simple comparison between Pradaxa and warfarin with respect to the numbers of post-marketing reports of bleeding in the  FDA’s Adverse Events Reporting System (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.

FDA has not changed its recommendations regarding Pradaxa.  Pradaxa provides an important health benefit when used as directed. 



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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63


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