Study Finds Pradaxa Risky for Patients Implanted with Artificial Heart Valves

Pradaxa has been tied to more serious adverse reactions, according to a new study on Behringer Ingelheim’s blood thinner.

The research revealed that when Pradaxa (dabigatran) is taken by patients with mechanical heart valves, there is an increase in risks for dangerous blood clots and bleeding around the heart according to HealthDay News. Lead researcher, Dr. Frans Van de Werf, chairman of the department of cardiovascular medicine at the University Hospitals Leuven in Belgium, says simply: “don’t use Pradaxa in patients with a mechanical valve.”

The trial had to be halted prematurely and the U.S. Food and Drug Administration (FDA) followed up with a “Black Box” warning that indicated that patients implanted with mechanical heart valves should not take Pradaxa over increased stroke or heart attack risks, according to HealthDay News. “It was hoped that a novel oral direct clotting inhibitor would provide similar or better protection for patients with mechanical heart valves without the need for [the] monitoring or dietary restrictions associated with warfarin,” said Dr. Gregg Fonarow, a professor of cardiology at the University of California, Los Angeles, HealthDay News reported.

For about 50 years, warfarin—also known by the brand name, Coumadin—was prescribed to patients diagnosed with atrial fibrillation (AF), an irregularity of the heartbeat, and others at risk of forming potentially fatal blood clots. Warfarin is an anticoagulant medication. Pradaxa is a blood-thinning medication used to reduce risks of stroke and blood clots in patients with non-valvular AF, a common heart rhythm abnormality; Pradaxa is not approved for patients with AF caused by heart valve problems. Pradaxa also inhibits thrombin, which is, explained News-Medical, the central coagulation activator in the body’s blood clotting system.

Both Pradaxa and warfarin can cause internal bleeding, but there are readily available antidotes for warfarin bleeding. A growing number of Pradaxa bleeding lawsuits allege the drug caused serious, uncontrollable bleeding side effects, including GI bleeding and cerebral hemorrhaging for which there is no reversal agent.

Following heart valve replacement, patients are normally prescribed blood thinners of anti-clotting medications to prevent a subsequent heart attack or stroke; however, these types of medications increase risks for bleeding, according to HealthDay News.

“While the vitamin K antagonist warfarin is very effective at preventing clotting-related complications of mechanical heart valves, its use requires lifetime monitoring, with at least monthly blood tests, dietary restrictions and the potential for multiple medication interactions,” Fonarow explained, according to HealthDay News. He noted that, unfortunately, the trial also revealed that, when it came to side effects, Pradaxa presented even more problems. “As a result of these findings, the FDA added a ‘black box’ warning to the medication label warning against using dabigatran and similar medications in patients with mechanical heart valves,” Fonarow said. The report was published September 26th in the New England Journal of Medicine.

For the study, 252 patients who underwent aortic or mitral valve replacement were randomly assigned Pradaxa or warfarin. Some patients underwent valve replacement within a week prior to the start of the study and others underwent surgery three months prior; 32 percent of the Pradaxa patients either had to have their doses changed or their treatment ceased and 5 percent of those suffered a stroke. There were no strokes reported in the warfarin group, according to HealthDay News; however. another 4 percent in the Pradaxa group suffered bleeding around the heart compared to 2 percent in the warfarin group.

A recent study revealed issues related to anti-coagulants, such as Pradaxa, and serious bleeding events. That study revealed that drugs such as Pradaxa were associated with increased risks for gastrointestinal (GI) bleeds when compared to traditional treatment, such as warfarin. Another relatively new study also found that Pradaxa may increase risks for viral infections, as well as increasing the severity of these infections.

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