FDA: Bleeding Risk With Dabigatran Similar to Warfarin

Emma Hitt, PhD


November 02, 2012

Bleeding rates associated with the use of dabigatran etexilate (Pradaxa, Boehringer Ingelheim) appear to be no higher than bleeding rates associated with warfarin when used as an anticoagulant to reduce the risk for stroke in patients with nonvalvular atrial fibrillation (AF).

According to a safety communication sent today by MedWatch, the US Food and Drug Administration's (FDA's) safety information and adverse event reporting program, the finding "is consistent" with observations from the large clinical trial, the Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY) trial, used to approve dabigatran.

Today's communication follows an FDA announcement from December 2011 stating that the agency was investigating postmarketing reports of serious bleeding events.

In the RE-LY trial, rates of fatal bleeding were 0.23% per year with 150 mg twice-daily dabigatran compared with 0.33% per year for warfarin. However, life-threatening bleeds were more common, numerically, in the 150-mg group than in the 110-mg group tested in the trial. The 110-mg dose is not approved in the United States.

Today's communication regarding the safety of dabigatran was based on an investigation of the actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of dabigatran compared with new users of warfarin. Data were collected from insurance claims and administrative data from FDA's Mini-Sentinel pilot of the Sentinel Initiative, a surveillance system that monitors the safety of FDA-regulated medical products.

The FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue, but the agency believes that dabigatran "provides an important health benefit when used as directed" and that healthcare professionals should adhere to the approved drug label.

"Patients with AF should not stop taking Pradaxa without talking to their healthcare professional," the FDA adds. "Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death."

Adverse events potentially related to dabigatran should be reported to MedWatch by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.