Safety Alerts & Recalls
What does this mean?
Taking this latest study’s findings into account, Pradaxa® continues to have a favorable benefit to risk profile and the FDA has not made changes to the prescribing information or recommendations for use.
If you take Pradaxa® or warfarin (Coumadin®, Jantoven®, and generics), you should continue taking your medicine as directed by your healthcare provider. Do not stop taking your medicine without first talking with your healthcare provider. Stopping the use of blood-thinning medications such as Pradaxa® and warfarin can increase the risk of stroke and lead to permanent disability and death.
Please follow up with your healthcare provider if you have any questions or concerns about this alert or your treatment.
Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:
--- Telephone: 1-800-332-1088
--- Fax: 1-800-332-0178
--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
--- Website: www.fda.gov/safety/medwatch
FDA Completes Study Reviewing Efficacy and Safety of Pradaxa® (dabigatran)
The U.S. Food and Drug Administration (FDA) has recently completed a new study comparing the blood thinner Pradaxa® (dabigatran) to the blood thinner warfarin (Coumadin®, Jantoven®, and generics) in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation (AF). This study is part of the FDA’s ongoing review of the efficacy and safety of Pradaxa®. It was conducted to better understand the risk of stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, heart attack, and death when either of these medicines are taken by patients with non-valvular AF who are 65 years or older.
The study included more than 134,000 Medicare patients and found that Pradaxa® was associated with: - a lower risk of stroke, bleeding in the brain, and death compared with warfarin
- an increased risk of major GI bleeding compared with warfarin
- a similar risk for heart attack compared with warfarin
This study’s findings, except with regard to heart attacks, are similar to the clinical study results that supported the FDA’s approval of Pradaxa®.
The FDA will continue to review anticoagulant use and the risk of bleeding and will update the public with any relevant information that becomes available.
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