The U.S. Food and Drug Administration (FDA) has granted special fast-track approval to a drug to counter a possible life-threatening Pradaxa side effect.

In October 2015, the FDA announced that they had granted accelerated approval to a drug called Praxbind (idarucizumab).

Praxbind is a reversal agent, designed to effectively turn off Pradaxa in the event of a life-threatening bleeding event, a possible Pradaxa side effect. In the event of severe Pradaxa bleeding, Praxbind acts as a sort of Pradaxa antidote.

As an anticoagulant or blood thinner, Pradaxa makes it harder for blood to clot. This can allow Pradaxa to decrease the risk of stroke, pulmonary embolism, and other conditions caused by blood clots forming within the body.

However, anticoagulants carry the risk of working too well, which may lead to uncontrollable bleeding, and there is a Pradaxa bleeding risk. Some patients taking anticoagulants experience severe bleeding from very minor wounds, and may bleed to death from minor internal or external injuries.

However, older anticoagulants like Warfarin have known reversal agents. This means that if a patient on Warfarin experiences uncontrollable bleeding, doctors can administer a high dose of vitamin K, which shuts down Warfarin, allowing the patient to clot and stop bleeding. But Pradaxa has been on the market since 2010, and this new “Pradaxa antidote” only received approval in 2015.

FDA Approves Pradaxa Antidote

Under the FDA’s Fast Track program, drug makers may apply for FDA approval with less than the usual rigor “for drugs for serious conditions that fill an unmet medical need,” according to the FDA’s website.

In this Fast Track program, a drug maker may apply when they have surrogate endpoints, or an indirect way of measuring the effectiveness of the drug. This study to try and find a way to reverse this Pradaxa side effect was approved through this Fast Track Program.

In this case, the FDA stated that two relatively small tests for Praxbind were used. A study of 283 healthy people found that Praxbind reduced the amount of Pradaxa in a patients blood and did not appear to cause health problems beyond a headache in some patients.

A second study of 123 patients who experienced uncontrollable bleeding with Pradaxa were given Praxbind to reverse this Pradaxa side effect. In 89 percent of these patients, Pradaxa managed to reverse the problem in less than four hours.

Outside of the FDA’s Fast Track program and similar options, FDA approval usually requires much larger tests with thousands of patients. The more patients are involved in a study, the stronger the study’s statistical data is.

Pradaxa Bleeding Lawsuits

The makers of Pradaxa are currently facing large-scale litigation over allegations that Pradaxa is a dangerous drug. So many Pradaxa lawsuits have been filed that the legal system has resorted to a process called a multidistrict litigation or MDL.

In MDLs, similar cases are coordinated to help streamline the legal system. Since Pradaxa lawsuits typically hinge on similar evidence and make similar claims of Pradaxa side effects, they have been grouped into a Pradaxa MDL, coordinated through a federal court in Illinois.

Pradaxa lawsuits within the Pradaxa MDL typically allege that the makers of Pradaxa did not adequately warn the public that there was, at the time, no known reversal agent for Pradaxa available, making Pradaxa more dangerous than other anticoagulants. Pradaxa lawsuits typically seek to recoup the cost of medical treatment, legal fees, and other costs allegedly stemming from Pradaxa lawsuits.

The Pradaxa Lawsuit MDL is In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the Southern District Court of Illinois.