Full approval of the Pradaxa bleeding reversal agent Praxbind occurred on April 17, 2018, nearly one year ago.

The U.S. Food and Drug Administration (FDA) granted full approval for Praxbind, known generically as idarucizumab. Its purpose was for the mitigation of out-of-control bleeding secondary to ingestion of Pradaxa, one of the New Oral Anticoagulant (NOAC) class of drugs, according to a PR Newswire post.

As with any blood thinning treatment regimen designed to prevent blood clots, a certain amount of risk is shouldered by the patient with regard to the possibility of developing the opposite problem—bleeding uncontrollably. Drugs like Praxbind, for Pradaxa bleeding reversal, are meant to slow or stop the problem.

Warfarin, a tried and true anticoagulant successfully in use for approximately six decades, had a known antidote if this happens—rapid infusion of Vitamin K. Many NOACs, however, did not have an antidote for many years.

Users of warfarin are instructed to avoid leafy green vegetables and foods that are high in Vitamin K in order for the drug’s effects to take hold. Additionally, a patient taking warfarin—often sold under the brand name Coumadin—often must have their blood levels tested to assure therapeutic range.

Issues with NOACs

Pradaxa—along with Eliquis and Xarelto—was marketed as a more convenient alternative to warfarin and as requiring less medical supervision. Once Pradaxa was approved by the FDA in October 2010, it was marketed by Boehringer Ingelheim on the basis of the convenience.

Pradaxa was supposed to only need once a day dosing, and no dietary changes or lab monitoring were needed. But at the same time, no reversal agent like warfarin’s Vitamin K was available.

This lack of a Pradaxa bleeding reversal agent had severe consequences during the seven and one-half years until Praxbind was approved. In the first quarter of commercial sales of Pradaxa, 307 adverse medical event reports were registered. These reports involved gastrointestinal bleeds and more generalized internal bleeding, brain bleeds, strokes, and cardiac arrests.

By the first anniversary of market approval, close to 300 patients had allegedly succumbed to bleeding side effects associated with Pradaxa. Patient advocates say these deaths might have easily been avoided if Boehringer Ingelheim had shown reasonable precaution for the populations it purported to serve.

According to a report by Pharma Intelligence, it was estimated that the availability of a reversal agent would cause sales of Pradaxa to rebound to high levels. At that time, initial data revealed that 80 of 81 patients experiencing baseline levels of anticoagulant effects were substantially reversed with Praxbind.

For those who suffered and died while taking this drug during the years it was on the market without an available Pradaxa bleeding reversal agent, news that the manufacturer could once again stand to make millions in profits is disconcerting at best.

Patients may have a legal claim against the manufacturer if they took Pradaxa and experienced out-of-control bleeding that was difficult or impossible to treat.