FDA Alerts
Pradaxa Reversal Rx Approved
The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
FDA Compares Risks of Pradaxa and Warfarin
FDA research has taken a closer look at the risks of two medications commonly used to lower the risk for stroke and blood clots.
FDA Safety Communication: Pradaxa
The US Food and Drug Administration (FDA) is informing healthcare professionals and the public that the blood thinner (anticoagulant) Pradaxa ( dabigatran etexilate mesylate ) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.
FDA Drug Safety Communication: Pradaxa
The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa ( dabigatran etexilate mesylate ) capsules.