Pradaxa Antidote May be Approved By End of 2015

Early results from a new study indicate that an experimental drug is able to successfully reverse the blood-thinning effects of the anticoagulant drug Pradaxa, and may be ready for release toward the end of 2015. In April 2015, the U.S. Food and Drug Administration (FDA) said it would conduct a priority review of the application to approve idarucizumab once the current study is complete.

The ongoing study, published recently in the New England Journal of Medicine, is being conducted to determine how the new drug, idarucizumab, works in real-life emergency situations when patients need immediate surgery or are suffering life-threatening bleeding as a result of anticoagulation. Although dangerous bleeding is relatively rare, it occurs in approximately 1.5 percent of Pradaxa patients every year.

According to the study, idarucizumab works by binding to Pradaxa and neutralizing its blood thinning activity. Reversal effects with the drug were immediate, normal blood clotting was restored within minutes, and idarucizumab did not appear to promote blood clotting.

Bleeding Events Related to Pradaxa

Serious bleeding events related to Pradaxa use have accounted for thousands of adverse effects and hundreds of deaths since the FDA approved the medication in 2010. One of the biggest concerns surrounding Pradaxa and other new oral anticoagulants is the fear that if a patient has a serious bleeding event, there is no specific antidote available to reverse the medication’s effects, unlike warfarin, currently the only oral anticoagulant drug with an approved reversal agent, vitamin K.

Although Pradaxa and other newer oral anticoagulants like Xarelto and Eliquis appear to offer advantages over warfarin in terms of preventing stroke in patients with non-valvular atrial fibrillation, major bleeding remains a significant risk associated with these medications, prompting thousands of lawsuits.

In May 2014, TorHoerman Law announced that the Pradaxa litigation that it helped spearhead was settled in the amount of $650,000,000, compensating nearly 4,000 claimants. TorHoerman Law is currently filing lawsuits on behalf of individuals that experienced uncontrollable bleeding incidents while using Xarelto and Eliquis.