Blood Thinners Pradaxa, Xarelto Have New Competitor in Eliquis

After twice delaying approval of the drug, the U.S. Food and Drug Administration (FDA) has now cleared Eliquis for the prevention of stroke and dangerous blood clots in patients diagnosed with non-valvular atrial fibrillation, the most common type of heart rhythm abnormality.

Eliquis, developed by Bristol-Myers Squibb and Pfizer, is the latest addition to a family of three next-generation blood thinner drugs approved by the FDA in the last two years; the others are Pradaxa and Xarelto.

FDA approval of Eliquis came after the drug’s approval in Japan and the European Union, and several months before the scheduled ruling set for March 17, 2013. The agency initially was expected to make the decision in March 2012, but requested more time to review new data.

By June 2012, the FDA had again postponed the drug’s approval as it awaited results from ARISTOTLE, a clinical study comparing the safety and effectiveness of Eliquis to warfarin, a more dated anticoagulant, in more than 18,000 patients with non-valvular atrial fibrillation.

New Drug, Familiar Risk
Eliquis, Pradaxa and Xarelto were all developed as alternatives to warfarin, which the FDA approved nearly 60 years ago. Although warfarin was once the go-to treatment for patients with atrial fibrillation not caused by a heart valve problem, its safe use requires regular blood monitoring by doctors.

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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