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Study Finds No Increased Risk of Pradaxa Side Effects

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Chicago, ILA recent study suggests that the risk of Pradaxa side effects is no greater than the risks associated with another, similar medication. Concerns have been raised about the risk of Pradaxa bleeding, prompting the US Food and Drug Administration (FDA) to undertake an evaluation of the drug. Although there have been reports of patients suffering serious consequences while taking Pradaxa, at least one study says the risks associated with Pradaxa are not increased.

The study, published in Circulation (the journal of the American Heart Association; 6/14/12), was conducted using results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) Randomized Trial. The RE-LY trial was conducted to determine the risk of bleeding events in patients who were given dabigatran (the generic of Pradaxa) and warfarin, a similar drug that has not been found to have the same risk of serious bleeding events.

Bleeding rates in the two groups were evaluated from seven days before an invasive procedure up to 30 days after the procedure. Among the invasive procedures included in the study were pacemaker insertion, dental procedures and joint replacement. Researchers in the RE-LY trial found that Pradaxa was not associated with an increased risk of bleeding events following invasive procedures.

"Compared with warfarin, dabigatran is associated with similar rates of perioperative bleeding and thrombotic complications, even among patients having major or urgent surgery," researchers reported.

On December 7, 2011, the FDA announced it was evaluating post-marketing reports of bleeding events in patients who use Pradaxa. At the time, FDA noted that serious bleeding, including bleeding that was potentially fatal, is a "well-recognized complication of all anticoagulant therapies." The agency further stated that a large clinical trial comparing Pradaxa and warfarin found similar rates of bleeding between the two drugs.

The FDA has undertaken the evaluation to determine whether the rate of bleeding in Pradaxa patients was more common than expected. While the evaluation continues, however, the agency says that the benefits of Pradaxa outweigh the concerns, when the drug is used as recommended.

Pradaxa is an anticoagulant medication used to reduce the risk of blood clots and related strokes. As with other anticoagulant medications, it has been linked to an increased risk of serious bleeding events. The concern about Pradaxa is that there is no antidote to the drug, so that once a minor trauma occurs, patients could be at risk of fatal consequences. Patients who use Pradaxa are urged to seek medical attention if they develop signs or symptoms of bleeding, including unusual bleeding from the gums, nose bleeds, heavier vaginal bleeding or uncontrollable bleeding.

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