Pradaxa is a prescription drug used to treat and help prevent blood clots in adults and some children. ... (diphenhydramine) a product you apply to your skin, such as hydrocortisone cream; ...

Pradaxa was associated with lower rates of overall bleeding and a higher rate of any GI bleeding (3.1% vs. 2.2%). The placebo-controlled RE-SONATE trial examined DVT/PE recurrence rate in patients ...

The RE-DUAL PCI™ trial explored anticoagulation with Pradaxa® (dabigatran etexilate) dual therapy without aspirin in non-valvular atrial fibrillation .

The letter will inform physicians that Pradaxa is now contraindicated in patients with mechanical heart valves. The change was based on a recent decision of the FDA, BI told its investigators.

Boehringer Ingelheim announced that it has reached a $650 million settlement in their state and federal cases in the U.S. regarding the blood thinner Pradaxa.

The FDA announced the results of a new study on Medicare patients comparing Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim Pharmaceuticals) vs. warfarin for risk of ischemic or clot ...

The methodology used by the FDA Mini-Sentinel project to assess safety risks for the Pradaxa bloodthinner is lacking, according to a non-profit formed by the FDA, PhRMA and the Foundation for the NIH.

Recent safety concerns among Pradaxa users, their families and some doctors, has caused the Food and Drug Administration to issue a safety review on Friday stating that the risk of serious bleeding in ...