CardioExchange Archive

April 30th, 2013

Anticoagulation Update: New Agent for Urgent Anticoagulation Reversal, Pradaxa Label Revised

Larry Husten, PHD

Here are two small but important changes in the anticoagulation field: FDA approves new product for urgent reversal of anticoagulation. The FDA yesterday approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Unlike plasma, which is currently the only available method to reverse […]

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April 4th, 2013

Registry Study Offers Reassurance About Safety and Efficacy of Dabigatran

Larry Husten, PHD

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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December 19th, 2012

Pradaxa To Be Contraindicated in Patients with Mechanical Heart Valves

Larry Husten, PHD

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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December 12th, 2012

Boehringer Ends Phase 2 Trial of Dabigatran in Mechanical Valve Patients

Larry Husten, PHD

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, 12-week randomized comparison of […]

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June 7th, 2012

Growing Popularity of Dabigatran Leads to Increased Complications

Larry Husten, PHD

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 includes the statement […]

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January 9th, 2012

Excess Risk for Cardiac Events Associated with Dabigatran

Larry Husten, PHD

A new meta-analysis finds that dabigatran is associated with a higher risk of myocardial infarction and acute coronary syndromes. An editorial raises questions about the enthusiasm to embrace new drugs.

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December 7th, 2011

FDA Undertakes Safety Review of Dabigatran (Pradaxa)

Larry Husten, PHD

The FDA announced today that it is initiating a safety review of dabigatran (Pradaxa, Boehringer Ingelheim). The review was prompted by reports of serious bleeding events in people taking the drug. Bleeding complications, the FDA acknowledges, are a “a well-recognized complication of all anticoagulant therapies.” The agency says it is “working to determine whether the reports of bleeding […]

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March 30th, 2011

FDA Warns Against Repackaging Dabigatran

Larry Husten, PHD

The FDA has issued a safety communication regarding dabigatran (Pradaxa). Because the drug is subject to product breakdown and loss of potency due to moisture, the FDA recommends that it should be dispensed and stored in its original packaging and that consumers avoid using pill boxes or pill organizers with it. Pradaxa is supplied as either […]

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October 26th, 2010

Dabigatran to Cost $237 per Month at the Drugstore

Larry Husten, PHD

It looks like Pradaxa (dabigatran) will cost about $237 a month at the drugstore counter. A Boehringer Ingelheim representative says the wholesale acquisition cost (WAC) of the drug is set at $6.75 per day for 2 pills. The price will apply to both the 150-mg and the 75-mg capsules.  According to knowledgeable experts, the retail […]

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September 20th, 2010

FDA Panel Unanimously Recommends Approval for Dabigatran

Larry Husten, PHD

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of  dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw […]

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