Pradaxa vs Xarelto: Comparing Blood Thinners

Until the last decade, the only option available for patients with nonvalvular atrial fibrillation to help control blood clots was Coumadin (also known as warfarin). While effective in preventing intracranial bleeding, patients on Coumadin have to endure regular blood tests and risk major bleeding complications. Now there are new drugs known as non-vitamin K antagonist oral anticoagulants (NOACs).

The two anticoagulants at the forefront of the blood thinner market are Pradaxa (dabigatran), made by Boehringer Ingelheim, and Xarelto (rivaroxaban), manufactured by Johnson & Johnson’s Janssen Pharmaceuticals division. Both of these blood thinners are considered by some doctors to be safer and more effective than Coumadin. But they still come with increased risk of severe bleeding that have resulted in patients filing both Xarelto lawsuits and Pradaxa lawsuits by the thousands. Additionally, they are more expensive and may impact the renal system with prolonged use.

Because of these issues, we decided to do a head-to-head comparison between the two biggest rivals in this class of new blood thinners. Patients trying to choose the right blood thinner should consider the following things when weighing their options.

FDA: Pradaxa Not for Patients with Mechanical Heart Valves

The Food and Drug Administration (FDA) issued a Drug Safety Communication recently informing the public and health care professionals that the blood thinner Pradaxa (dabigatran) should not be used in people with mechanical heart valves.

Forbes reported that the drug’s manufacturer, Boehringer Ingelheim, has told its Pradaxa clinical trial investigators that it will be sending a Direct Healthcare Professional Communication (DHPC) – also known as a “Dear Doctor Letter” – to health care professionals. The letters are based on the FDA’s recent decision and will inform doctors that Pradaxa is contraindicated in patients with mechanical heart valves.

In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also recommended that the drug should not be used in patients with artificial heart valves. This announcement came a week before the FDA’s Drug Safety Communication.

More Strokes, Heart Attacks Caused by Pradaxa than Warfarin

The FDA and EMA made their recommendations based on the findings of the RE-ALIGN clinical trial. The Boehringer-sponsored trial was stopped prematurely when participants with mechanical heart valves using Pradaxa began experiencing strokes, heart attacks and blood clots forming on valves. The same risk of these side effects did not apply to those using warfarin. There was also a higher incidence of bleeding after valve surgery in those using Pradaxa.

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