Pradaxa, Xarelto Should Not Be Used In Patients With Chronic Kidney Disease, Doctors Warn

New clinical guidelines on managing anticoagulation in patients with atrial fibrillation warn that some newer blood thinners may be too dangerous for patients with kidney problems. 

The Journal for the American Medical Association (JAMA) published a synopsis this week of clinical guidelines issued by several professional medical groups regarding the management of patients with atrial fibrillation, including warnings against the use of medications like Xarelto, Pradaxa and Eliquis among patients with end-stage chronic kidney disease (CKD).

The guidelines target all patients with atrial fibrillation and were developed last year by the American College of Cardiology (ACC) and the American Heart Association (AHA) in collaboration with the Society of Thoracic Surgeons.

Researchers looked at the long-established blood thinner Coumadin (warfarin), as well as new novel oral anticoagulants introduced in recent years, such as Xarelto (rivaroxaban), Pradaxa (dabigatran), and Eliquis (apixaban).

In one of two major recommendations comprising the guidelines, the groups warned of cautious use of all blood thinners in patients with chronic kidney disease. The guidelines set specific instructions on how to use warfarin for all patients with CKD. However, it called for reduced doses of Pradaxa, Xarelto, and Eliquis in moderate to severe CKD, and warned that neither Pradaxa nor Xarelto should be given to patients with end-stage CKD.

New Blood Thinner Bleeding Risks

Pradaxa was introduced by Boehringer Ingelheim in late 2010 as the first member of a new class of anticoagulants. Xarelto was introduced by Bayer and Janssen Pharmaceuticals in 2011, as the second member of this class. Eliquis was introduced by Pfizer last year.

While all blood thinners carry a risk of bleeding injury, Pradaxa and Xarelto have been linked to a surprising number of problems as more and more patients are switched from warfarin to the new anticoagulants.

Unlike warfarin, where doctors can quickly reverse the blood thinning effects of the medication if bleeding problems develop, Pradaxa, Xarelto and Eliquis were introduced without an effective reversal agent. As a result, many doctors have reported being unable to stop or control hemorrhaging or bleeding that develops among users of the drugs.

Several recent studies have also raised questions about the marketing claims made by the makers of these new anticoagulants, suggesting that blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.

In July 2014, an investigative report published by The BMJ suggested that the makers of Pradaxa failed to provide the FDA with important clinical trial data that suggested users may benefit from regular blood monitoring to make sure the drug did not build up in their bloodstream, increasing the risk of bleeds.

In another study published by the Journal of Cardiology in October 2014, researchers indicated that Xarelto monitoring may have helped doctors understand the effects of the drug on a particular patient and their associated bleeding risk.

Thousands of Pradaxa lawsuits and Xarelto lawsuits have been pursued against the drug makers, alleging that inadequate warnings were provided about the bleeding risks, and that all potential reversal agents should have been explored before the drug was introduced, which would have made the medication safer.