March 7, 2012 — A New Zealand study has found that Pradaxa (dabigatran) has a higher risk of bleeding than its alternative, Coumadin (warfarin). Researchers warned doctors to use caution when prescribing Pradaxa to people who are over 80 years of age or have impaired renal function. The study also identified four major risk factors associated with bleeding complications.
The authors of the study are a group of hematologists from New Zealand who became alarmed after treating a large cluster of patients who had suffered serious bleeding after using Pradaxa. The study was published on February 1, 2012 in the Journal of the American College of Cardiology.
In two months, there had been 78 bleeding episodes, including 12 major bleeds, one of which may have caused a patient’s death. Most of the bleeding events occurred in people who were over 80 years of age or had impaired renal function. Around 25% of the bleeding events were caused by prescriber error, suggesting a lack of awareness about Pradaxa side effects.
The audit revealed four factors contributing to bleeding complications:
- 1. Prescriber error caused 25% of bleeding events. The most common mistake was prescribing the drug to patients with impaired renal function
- 2. Impaired renal function makes it difficult or impossible for the body to remove Pradaxa from the body. This can lead to excessively high levels of Pradaxa in the bloodstream, which can contribute to severe, uncontrollable bleeding.
- 3. Patient age was a contributing factor. Two-thirds of patients who had suffered bleeding caused by Pradaxa were over 80 years old. 50% of people who are over 80 and have atrial fibrillation have impaired renal function, which increases the likelihood of severe bleeding
- 4. Only dialysis can reverse the blood-thinning effects of Pradaxa. When patients suffered bleeding, doctors had difficulty stopping the bleeding because Pradaxa prevents blood from clotting. Coumadin (warfarin), the alternative to Pradaxa, can be reversed with a simple dose of Vitamin K.
The New Zealand researchers also noted that the patients in their study differed significantly from the patients in the RE-LY clinical trial, which was the foundational safety study of Pradaxa. In the RE-LY study, the average age of participants was 71 with a median weight of 83 kg. The majority of the patients in the New Zealand study were over 80 years old, had moderate or severe renal impairment, and body weight under 60 kg.
The New Zealand researchers highlighted the need for post-marketing safety studies of medications, which may indicate when a drug poses a particularly high risk to a certain group of people. In recent months, Boehringer Ingelheim has made an effort to warn doctors to test patients for renal impairment before prescribing Pradaxa, and also periodically during treatment.
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