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FDA safety review: Blood thinner Pradaxa no more likely to cause bleeding than warfarin

November 06, 2012

By Jean Williams

The anticoagulant dabigatran (Pradaxa) does not appear to cause higher bleeding rates in patients than warfarin, another blood thinning medication, according to an assessment by the U.S. Food and Drug Administration.

The FDA launched a safety evaluation of Pradaxa following a large number of post-marketing reports of serious bleeding in patients taking the drug last year. The agency conducted its evaluation using insurance claims and administrative data from the agency's Mini-Sentinel pilot of its Sentinel Initiative, which is a project to create an active surveillance system to monitor the safety of FDA-regulated medical products. Mini-Sentinel uses pre-existing electronic health care data from multiple sources.

Dabigatran (Pradaxa) and warfarin (brand names Coumadin and Jantoven) are important medications used to reduce the risk of stroke and blood clots in patients with nonvalvular atrial fibrillation, the most common type of heart rhythm abnormality, according to the FDA.

“The risk of bleeding is a well-recognized risk of anticoagulant drugs,” the FDA said in its safety review. The FDA maintains that Pradaxa, “provides an important benefit when used as directed.”

Dentists who are concerned about periprocedural and postprocedural bleeding should contact the patient's cardiologist regarding the patient's anticoagulant regimen and discuss optimal patient management before discontinuing these medications. Stopping therapy increases the risk of thromboembolic events.

“It is important for dentists to conduct a thorough medical history and update it regularly,” said Dr. Daniel Meyer, senior vice president of Science/Professional Affairs, ADA Division of Science. “Part of the medical history is to determine if patients are taking any medications which might influence or have an effect on their oral health and/or medical care. When issues, concerns or questions arise dentists should consult with the patient's primary care health care provider or specialist prior to providing definitive care.”

The ADA has resources on on anticoagulant, antiplatelet medications and dental procedures.

The FDA is conducting two more protocol-based observational assessments of Pradaxa using the Mini-Sentinel data and “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 and will communicate any relevant information on the risk of bleeding and Pradaxa,” the review said.

Health care professionals and patients are encouraged to report adverse events related to the use of Pradaxa to FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Call the FDA at 800.332.1088 to request a reporting form, or complete and submit a form at