March 7, 2012 — Doctors from New Zealand are warning that Pradaxa (dabigatran) poses higher risks to people who are over 80 years old or have impaired renal function. In these populations, risks from Pradaxa may be higher than its alternative, Coumadin (warfarin). The doctors also identified four risk factors that are contributing to high numbers of bleeding events caused by Pradaxa.
The doctors who conducted the research are hematologists from New Zealand. Soon after Pradaxa was approved in New Zealand, they became alarmed at a cluster of severe bleeding events. In two months, there were 78 cases of bleeding, including 44 that the doctors handled personally. Of these, 12 cases were severe bleeding. One severe bleeding event may have caused the death of a patient.
The doctors investigated each of these episodes and found four contributing factors. Their analysis was published in the Journal of the American College of Cardiology on February 1, 2012.
The factors contributing to severe bleeding were:
- 1) Prescriber error. This contributed to 25% of the bleeding events. Doctors mistakenly prescribed Pradaxa to patients who had impaired renal function.
- 2) Impaired renal function. A patient with this complication is unable to eliminate Pradaxa from the body. Over time, Pradaxa increases to dangerous levels in the bloodstream. This can contribute to a higher rate of severe, uncontrollable bleeding events.
- 3) Age of the patient. Though the safety labeling on Pradaxa warns that bleeding risks increase for patients over 75 years old, more than two-thirds of the study’s patients who had suffered bleeding were over 80 years old. Furthermore, many of these patients also had impaired renal function.
- 4) No reversal agent. Pradaxa prevents blood from clotting, but sometimes a patient needs their blood to clot, such as after an injury or unexpected surgery. Unfortunately, there is no way to remove Pradaxa from a patient’s bloodstream except through dialysis, which can take hours. Pradaxa’s lack of reversal agent was blamed for the death of an 83 year-old man who fell, hit his head, and suffered minor bleeding that became a fatal cerebral hemorrhage.
The researchers in New Zealand also noted that the demographic of people who suffered bleeding was different from the group in the RE-LY clinical trial, the pivotal study that established Pradaxa’s safety. In the RE-LY study, the average age of patients was 71, with an average weight of 83 kg. The New Zealand doctors noted that the patients most likely to suffer side effects were over 80 years old, weighed less than 60 kg, and had renal impairment that was moderate or severe.
The researchers stressed the need for post-marketing analysis of medications to watch for signs that a drug might be particularly risky for certain people. The drug company responsible for Pradaxa, Boehringer Ingelheim, has made an effort to increase awareness among doctors that they need to test new Pradaxa patients for renal impairment, and renal function should be tested periodically during treatment.
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