At long last, the Pradaxa bleeding antidote has been granted accelerated approval by the FDA, which will benefit numerous Pradaxa patients.

This newly approved reversal agent is meant to stop any uncontrollable internal bleeding injuries caused by the drug’s blood-thinning mechanism. Boehringer Ingelheim is reportedly very pleased by this development, and hopes that Praxbind (Idarucizumab) will be available on the market soon.

According to the FDA’s Drug Evaluation and Research, experts had acknowledged the vital need for a Pradaxa antidote due to the popularity of Pradaxa and the frequency of bleeding reports.

The approval of Praxbind is expected to be vital against life-threatening internal bleeding events. Praxbind is the first reversal agent approved of to use with the new-generation anticoagulant. It works by negating the blood thinning effect and is given through intravenous injection.

The FDA’s decision was based on three trials involving 283 healthy Pradaxa patients, who were at risk for internal bleeding events. When given Praxbind, subjects immediately experienced rescued internal bleeding, with the most common side effect being a headache.

In a different trial, 123 patients were prescribed Pradaxa and had been given Praxbind due to uncontrollable bleeding or had to undergo emergency surgery.

The results of this ongoing trial indicates that Praxbind had fully reversed the Pradaxa bleeding events in only four hours. For this trial, the most common side effects included: hypokalemia, confusion, constipation, fever, and pneumonia.

The Praxbind label recommends that patients resume their anticoagulant prescriptions as soon as the doctor determines, as therapy should be continued if appropriate.

Praxbind was approved under the FDA’s accelerated approval program, which allows the agency to approve drugs for a needed medical purpose, and has been reasonably predicted to benefit patients.

This program was established to help patients gain access to vital treatment drugs, but companies still need to submit additional clinical information after approval to confirm the product’s benefits.

While the approval of Praxbind is a landmark in American pharmaceutical history, it does not help the numerous patients who have already suffered Pradaxa bleeding injuries.

Pradaxa Complications

Pradaxa was approved by the FDA in 2010, and was the first anticoagulent to be released in the United States since Warfarin. This drug was meant to directly compete with Warfarin, and was advertised to be more efficient and more convenient.

Not long after its release, Pradaxa soon outpaced Warfarin in popularity and had eventually inspired American pharmaceutical companies to try their luck in the anticoagulant market, with the release of Xarelto and Eliquis in 2011 and 2012, respectively.

Patients are most commonly prescribed Pradaxa to treat atrial fibrillation, and to ultimately prevent stroke. While this drug has been reported to work well, it was soon discovered that Pradaxa and the other new-generation anticoagulants lacked two major safety features of Warfarin.

In contrast to the traditional anticoagulant, Pradaxa, Xarelto and Eliquis are prescribed in a single dose and do not require frequent medical monitoring. The other difference being the lack of bleeding antidote, with Warfarin patients being able to take a large dose of vitamin K in the case of internal bleeding events.

Despite the severity of this information, Boehringer Ingelheim had allegedly chosen to omit a bleeding caution from Pradaxa’s warning label. Critics allege that the company did this in order to protect the drug’s market value, earning numerous product-liability lawsuits from injured Pradaxa patients.