Studies Comparing Risk of Bleeding from Pradaxa Vs. Warfarin Have Conflicting Results

Two new studies that attempted to evaluate whether the risk of bleeding from Pradaxa is greater than that of Warfarin came up with conflicting results.

Study of surgical patients finds similar bleeding risk for both anticoagulants

A study that used information from the Re-LY clinical trials found the risk of bleeding from Pradaxa use to be similar to that of Warfarin. That study was published in Circulation, the journal of the American Heart Association.

The study focused on patients with non-valvular atrial fibrillation who were having surgery. The patients were observed from seven days before their surgery to 30 days after their surgery. The study found that the percentage of patients who experienced side effects of Pradaxa (dabigatran) including internal bleeding, heart attack, stroke, pulmonary embolism, and death was similar to that of Warfarin. In addition, patients on Pradaxa were able to take the drug closer to the time of their surgery than patients on Warfarin, because of risk of bleeding from Warfarin increases two to three times if the medication is taken within 48 hours of having surgery.

Study of patients in the “real world” finds greater risk of Pradaxa complications

In contrast, a study that evaluated complications of the two drugs in a “real world” setting found the risks from Pradaxa to be higher. Results of that study, called “Dabigatran in the Real World,” were announced on May 4, 2012 at the 2012 Thrombosis and Hemostasis Summit of North America. The study was conducted at an anticoagulation clinic and tracked 113 patients who were initially on Warfarin but who were then switched to Pradaxa at the request of their physicians. During the Warfarin treatment period, the only major complication was one patient hospitalized for Warfarin toxicity. But during the Pradaxa treatment period, there was one death from internal bleeding, four other bleeding episodes, one case of deep vein thrombosis, one atrial thrombus, one transient ischemic attack, and four cases of gastrointestinal side effects.

In 2011, the FDA received more than 500 complaints about internal bleeding from Pradaxa – more than that of any other medication. The complaints included 120 reports of deaths.

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