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–Compared to dabigatran, rivaroxaban was associated with more intracranial and other serious bleeds. A new observational study finds that patients who take rivaroxaban (Xarelto, Johnson…
More Questions Raised About Boehringer Ingelheim’s Pradaxa
Once again dabigatran (Pradaxa) has raised the wrath of the critics. Several articles and an editorial published today in The BMJ raise more questions and concerns about…
Boehringer Ingelheim Settles US Pradaxa Litigation For $650 Million
Boehringer Ingelheim said today that it will pay $650 million in a “comprehensive settlement” of lawsuits over Pradaxa (dabigatran), the company’s novel anticoagulant. The company said that…
FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa
In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the…
Boehringer Ingelheim’s Pradaxa Gains New Indication
The new oral anticoagulants continue to gain additional indications from the FDA. Earlier today Boehringer Ingelheim announced that the FDA had approved Pradaxa (dabigatran) for the treatment…
FDA Plans New Safety Assessment Of Dabigatran (Pradaxa)
Since the approval of dabigatran (Pradaxa, Boehringer Ingelheim) in Europe in 2008 and in the US in 2010 there have been persistent and lingering concerns about the…
New Trial Confirms Role For Pradaxa In Venous Thromboembolism
A new study helps support a role for the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE). The RE-COVER II…
Large Study Finds Favorable Risk-Benefit Profile For The New Anticoagulants
A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in…
Disappointing Results with Dabigatran for Mechanical Valves
Despite being more durable than bioprosthetic valves, mechanical heart valves are often not chosen because of the requirement for lifelong anticoagulant therapy. It has been…
Anticoagulation Update: New Agent For Urgent Anticoagulation Reversal, Pradaxa Label Revised
Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation. … Pradaxa label gains boxed…