Reversing the effect of Pradaxa also exposes patients to the risk of blood clots and stroke from underlying diseases such as atrial fibrillation.
Side effects of the drug however included hypokalaemia (low potassium), confusion, constipation, fever, pneumonia and headache. “ approval offers the medical community and important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can't be controlled.”Īnother trial of 123 patients taking Pradaxa who received Praxbind due to uncontrolled bleeding or for emergency surgery showed that the anticoagulant effect of Pradaxa was fully reversed in 89% of patients within four hours of receiving Praxbind. Richard Pazdur, director of the office of hematology and oncology products in the FDA's center for drug evaluation and research, said: “The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug's effects is medically necessary. In the healthy volunteers who were given Praxbind there was a significant and immediate reduction in the amount of Pradaxa in participants' blood that lasted for at least 24 hours.
The safety and efficacy of Praxbind (idarucizumab) was studied in three trials involving 283 volunteers taking Pradaxa (dabigatran). The FDA has approved Boehringer's Praxbind for use when the reversal of anticoagulant Pradaxa is required in emergency situations.
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