Report Highlights Pradaxa Bleeding Dangers


Yet again, medical professionals are emphasizing the safety risks of Pradaxa (dabigatran). The Journal of Neurosurgery has published a report, citing a case where a Pradaxa patient died from a brain hemorrhage after a ground-level fall. The oral anticoagulant has been undergoing a safety review in the US since December, shortly after a large number of Pradaxa-related were reported to the EMA database.

Initially approved by the U.S. Food and Drug Administration (FDA) in October 2010, Pradaxa is a direct thrombin inhibitor used to prevent blood clots and stroke in patients with atrial fibrillation, a condition in which the patient experiences an abnormal heart beat. At its release, Pradaxa was expected to replace Coumadin (warfarin), a previous oral anticoagulant. Pradaxa’s advantages over Coumadin, such as minimal drug and food interactions and lesser monitoring, made it seem like a preferable choice to some patients. However, news regarding the drug’s bleeding risks may put a damper on these perceived benefits.

Pradaxa has been undergoing a safety review by the FDA since December, after EudraVigilance, the European Medicines Agency (EMA) database, received a spontaneous report of 256 deaths associated with Pradaxa the month before. This occurrence however, was not the first time the drug’s safety was brought into question. The Institute of Safe Medication Practices, a non-profit organization in the US, has been warning about the increased bleeding risks of Pradaxa since February, particularly with kidney patients. Japanese health regulators expressed similar concerns in August, after receiving reports of patients who suffered gastrointestinal (GI) bleeding while taking Pradaxa. Then in October, the Committee for Medicinal Products for Human Use (CHMP) required the German-based manufacturer Boehringer Ingelheim, to update its safety information. The new safety regulations require physicians in Europe to assess a patient’s renal functions before prescribing Pradaxa. An annual follow-up is advised in patients 75 years
or older, with further assessment if elderly patients show signs of failing kidney health.

In January, the ISMP released reports of over 500 cases of hemorrhaging linked to the use of Pradaxa. To make matters worse for Boehringer, last month a team of New Zealand hematologists wrote to the New England Journal of Medicine, pushing for better prescriber education following a review that identified 78 cases of bleeding, a dozen of which involved major hemorrhaging; in one of these cases, it is suspected of causing the patient’s death.

Now, there is yet another report of fatal hemorrhaging in a patient taking Pradaxa. The report discusses an 83-year old patient who died of a cerebral hemorrhage after a ground-level fall in his home. A month earlier, he started taking Pradaxa twice a day to treat his new-onset atrial fibrillation. The case report highlights the irreversible bleeding risks with Pradaxa; there is no proven antidote to stop the hemorrhaging once it starts. While Coumadin has disadvantages, the bleeding it induces can be effectively treated with vitamin K. Given the amount of controversy surrounding Pradaxa during its short time on the market, it seems the report is only further damaging the drug’s safety profile. “The authors stress that a high index of suspicion for catastrophic hemorrhage is required in patients taking dabigatran so that the limited management options can be evaluated and implemented without potentially life-threatening delay.” the report stated.