Dabigatran with Warfarin
May 14, 2014
FDA is informing the public of new data comparing safety of dabigatran (Pradaxa®) with warfarin in over 134,000 Medicare patients 65 years of age or older. Dabigatran and warfarin are blood-thinning agents prescribed to help prevent stroke and blood clots in patients with non-valvular atrial fibrillation.
The study found important safety differences between the 2 drugs. Dabigatran was associated with a lower risk of bleeding in the brain, clot-related strokes, and death, compared with warfarin in patients who were new users of blood thinning therapy. However, dabigatran was associated with increased risk of major gastrointestinal bleeding compared with warfarin. Both drugs showed similar risk for myocardial infarction.
The Medicare study is part of an ongoing review of dabigatran being conducted by FDA. FDA considers dabigatran to have a favorable risk to benefit ratio and has made no changes to dabigatran product labeling in light of this latest data. Patients are advised to make no changes in their blood-thinner therapy without first consulting a health care professional, as this could result in serious adverse events such as stroke or death.
See the links below for related safety communications. Adverse events associated with dabigatran or warfarin can be reported to the MedWatch safety program using the link below.
Additional information is available at the following links:
- MedWatch Alert – May 13, 2014
- Drug Safety Announcement – May 13, 2014
- Related Safety Announcement – December 19, 2012
- Related Alert – November 5, 2012
- Related Drug Safety Communication – November 2, 2012
May 14, 2014; University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.