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Study, FDA Warn of Pradaxa's Rising Risks of Bleeding, Blood Clots Among Patients with Artificial Heart Valves

Sep 27, 2013

New evidence shows that using the blood thinner drug Pradaxa in patients that rely on an artificial heart valve increases the risk of severe bleeding and blood clots near the heart.

HealthDay News reports that researchers in Belgium are the latest to find a dangerous side effect linked to Pradaxa. In fact, a study author at University Hospitals Leuven warned that doctors should avoid prescribing Pradaxa in patients with a heart valve device.

The risk of severe bleeding and blood clots near the heart in patients with an artificial heart valve taking Pradaxa is so grave that the clinical trial testing the drug’s efficacy in this circumstance was stopped early. The results have also prompted the U.S. Food and Drug Administration to place its most serious warning, the Black Box warning, on safety labels of Pradaxa to indicate this risk, HealthDay News reports.

We have been reporting on the dangerous side effects of Pradaxa since it was introduced on the U.S. market as an alternative blood thinner drug to warfarin. In addition to the risks noted in this most recent study, patients taking Pradaxa who do not have an artificial heart valve also face a risk of severe bleeding. These bleeding episodes can become fatal and since there is no antidote to stop Pradaxa-induced bleeding, doctors are often powerless to stop it.

Researchers were testing Pradaxa in patients with artificial heart valves because using warfarin requires constant monitoring and necessitates that a patient use diet restrictions to prevent future blood clots. This new study found that blood clots can occur when using Pradaxa in patients with an artificial heart valve, HealthDay News adds in its report.

During the study, more than 250 patients were assigned to take Pradaxa. Nearly one-third of those patients had to have their Pradaxa dosage adjusted or stopped because the risk of bleeding or blood clots was apparent. Five percent of the participants taking Pradaxa during the study suffered a stroke. Just one patient taking warfarin in a comparison group of study participants suffered a similar fate during the research period, HealthDay News reports. Four percent of the patients taking Pradaxa suffered a severe bleeding episode around the heart, the study authors noted.

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