FDA Approves Anticoagulant Reversal Agent

The U.S. Food and Drug Administration (FDA) approved on Oct. 16 Praxbind (idarucizumab), a reversal agent for the anticoagulant Pradaxa (dabigatran). The reversal agent is for intravenous injection and should be used in emergency situations when bleeding needs to be controlled in patients taking Pradaxa.

Praxbind works by binding to the Pradaxa compound to neutralize the effect of the anticoagulant, leading to an immediate reduction of Pradaxa in patients’ blood, lasting at least 24 hours. According to the Agency, the most common side effect from taking Praxbind is headache.

Read the FDA’s announcement

Clinical Topics: Anticoagulation Management, Novel Agents

Keywords: Anticoagulants, Benzimidazoles, Headache, Hemorrhage, Injections, Intravenous, Pyridines, United States Food and Drug Administration, beta-Alanine

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