Pradaxa

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.

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.

A Promising Drug With a Flaw

Dr. Bryan A. Cotton, a trauma surgeon in Houston, had not heard much about the new anticlotting drug Pradaxa other than the commercials he had seen during Sunday football games.

Then people using Pradaxa started showing up in his emergency room. One man in his 70s fell at home and arrived at the hospital alert and talking. But he rapidly declined. “We pretty much threw the whole kitchen sink at him,” recalled Dr. Cotton, who works at Memorial Hermann-Texas Medical Center. “But he still bled to death on the table.”

Unlike warfarin, an older drug, there is no antidote to reverse the blood-thinning effects of Pradaxa.

“You feel helpless,” Dr. Cotton said. The drug has contributed to the bleeding deaths of at least eight patients at the hospital. “And that’s a very bad feeling for us.”

Pradaxa has become a blockbuster drug in its two years on the market, bringing in more than $1 billion in sales for its maker, the privately held German drug maker Boehringer Ingelheim.

But Pradaxa has been linked to more than 500 deaths in the United States, and a chorus of complaints has risen from doctors, victims’ families and others in the medical community, who worry that the approval process was not sufficiently rigorous because it allowed a potentially dangerous drug to be sold without an option for reversing its effects.

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