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 the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the  investigations editor for The BMJ, casts doubt on the reliability…

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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 it expects the settlement will resolve about 4,000 current cases against the company in the US. … Click here to read the full post on Forbes.  …

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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 sometimes controversial drug. The FDA study of 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared to warfarin….

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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 of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE). …  Click here to read the full post on Forbes.    …

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Registry Study Offers Reassurance About Safety And Efficacy Of Dabigatran

As the first new oral anticoagulant since warfarin, dabigatran (Pradaxa, Boehringer-Ingelheim) has been subject to intense concerns over its safety and efficacy in a real-world population. Last November an FDA investigation found no indication that bleeding rates for dabigatran were any higher than bleeding rates for warfarin. A new study from Scandinavia, published in the Journal of the American…

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FDA Officials Calm Concerns Over Excessive Bleeding With Dabigatran

Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases…

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Two Experts Help Sort Out The New Generation Of Anticoagulants

Don’t miss this very practical discussion about the new generation of anticoagulants and the short term loan costs to cover them over on CardioExchange. Here are a few excerpts. Christian Thomas Ruff: I believe the addition of the 3 currently approved novel anticoagulants (dabigatran, rivaroxaban, and apixaban) will eventually translate into a greater proportion of eligible patients…

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Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves

Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that…

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Boehringer Ends Phase 2 Trial Of Dabigatran In Mechanical Valve Patients

Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board The RE-ALIGN trial was an open-label,…

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FDA Investigation Finds No Excess Bleeding Risk For Dabigatran

In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the…

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Setback For Trial Studying Dabigatran After Mechanical Valve Surgery

Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase…

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Growing Popularity Of Dabigatran Leads To Increased Complications

Since its approval in the United States in October 2010 dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now…

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Study Explores Role of Periprocedural Dabigatran in AF Ablation

Updated with a comment from John Mandrola– As dabigatran becomes more widely used in atrial fibrillation (AF) patients, electrophysiologists are now trying to figure out how to handle anticoagulation in patients taking dabigatran (Pradaxa) for whom AF ablation is planned. In a new study published in the Journal of the American College of Cardiology, Dhanunjaya Lakkireddy and colleagues…

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