Pradaxa Problems Pose Serious Concerns for U.S. Heart Doctors: Report

Reports involving hundreds of patient deaths on Pradaxa have increased concerns about the safety of a new breed of blood thinners. 

According to a Reuters report, some heart doctors are alarmed at the recent reports involving uncontrollable bleeding problems with Pradaxa, as well as with Xarelto, another new medication that is part of the same class of anticoagulants.

Pradaxa and Xarelto were both introduced in recent years as a replacement for Coumadin (warfarin), which has been the most widely used anticoagulant for decades.

The medications have been promoted as superior alternatives to warfarin, because they are easier to use and require less follow up monitoring. However, reports of severe bleeding problems, in which doctors were unable to stop the hemorrhage due to the lack of a reversal agent for the new medications, has caused concern over the safety of medications and led to investigations by health regulators in the United States, Europe and Canada.

In October 2010, Boehringer Ingelheim introduced Pradaxa (dabigitran) as the first in a new class of anticoagulants, known as “direct thrombin inhibitors.” However, the drug maker has faced criticism and a number of Pradaxa lawsuits over their failure to adequately warn patients and the medical community that the medication does not have an antidote to reverse the blood thinning effects. With warfarin, if bleeding problems develop while on the medication, doctors can often reverse the effects of the medication with a dose of Vitamin K.

During 2011, the first full year that Pradaxa was available in the United States, it was associated with more adverse event reports submitted to the FDA than any other medication. According to a report by the Institute for Safe Medication Practices (ISMP), the FDA received at least 3,781 reports involving serious injuries associated with Pradaxa, including 2,367 reports of hemorrhage and 542 patient deaths. By comparison, warfarin was linked to 1,106 adverse event reports and 72 patients deaths.

Some doctors say that the problems with Pradaxa will abate as doctors learn how to use the drug better and determine which patients should not be given the medication.

One important issue is testing of patients’ kidney functions. Pradaxa is cleansed from the body by the kidneys. If the patient has kidney problems lowering their ability to function, Pradaxa can build up in the blood to overdose levels, increasing the likelihood of a bleeding event.

Following a review of the safety concerns with Pradaxa by the European Medicines Agency (EMA), the regulatory agency decided not to issue a Pradaxa recall, but recommended that stronger warnings be placed on the medication about the bleeding risks, including more specific guidance on when Pradaxa should not be used and how to manage bleeding problems that do occur.