An antidote for Pradaxa side effects has been approved by the FDA. This could make Pradaxa safer by giving doctors an option in the case of serious Pradaxa bleeding.

The Pradaxa antidote or reversal agent was announced on Oct. 16, 2015 by the Food and Drug Administration (FDA). The FDA’s statement quoted the agency’s Director of the Office of Hematology and Oncology Products, Dr. Richard Pazdur in saying:

“The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary,” according to a statement by Dr. Richard Pazdur, Director of the FDA’s Office of Hematology and Oncology Products.

The new drug, called Praxbind, was approved through the FDA’s accelerated approval program. This program exists to approve drugs that meet a serious need for which there are no existing drugs — in this case a specific treatment for Pradaxa bleeding events.

It still requires testing, but much less testing than regular FDA protocols. Some side effects including low blood potassium levels, mental confusion and others have been reported, but in 89 percent of cases Praxbind was able to reverse Pradaxa bleeding within four hours.

Since Pradaxa bleeding may be life threatening, the FDA ruled that despite the reported side effects, Praxbind was worth approving.

Pradaxa bleeding lawsuits have alleged that Pradaxa is more dangerous than older anticoagulants, mostly because there was no Pradaxa reversal agent available. Hundreds of Pradaxa lawsuits have been filed over Pradaxa bleeding.

The Pradaxa bleeding side effect stems from the way Pradaxa works. Pradaxa is a newer-generation anticoagulant, a drug designed to make it harder for blood to clot. Though clotting is a normal part of the healthy healing process, the process can misfire and dangerous blood clots can form within the body, where they may cause strokes, certain types of heart attack, and pulmonary embolisms by blocking vital tissues’ blood supply.

But all anticoagulants carry the risk of working too well in stopping clot formation and can cause uncontrollable external and internal bleeding from minor wounds.

Pradaxa lawsuits that have been filed hold that Pradaxa bleeding has had a special risk. Prior to Praxbind’s approval, there was no approved, specific treatment to reverse Pradaxa bleeding.

Older anticoagulants such as warfarin worked by interfering with a different part of the clotting process, which involved using Vitamin K. This meant that patients on Warfarin had to strictly avoid Vitamin K.

Since Pradaxa attacks a different step of the clotting process, patients didn’t need to avoid foods rich in Vitamin K. But this “weakness” of older drugs like Warfarin also meant that if a patient suffered uncontrollable bleeding, doctors could give them a high dose of Vitamin K to “turn off” the drug.

Pradaxa was on the market for nearly five years before a reversal agent was discovered. This meant that in the case of Pradaxa bleeding, doctors had to try transfusions and other nonspecific treatments to try and stop Pradaxa bleeding incidents.

Pradaxa lawsuits have alleged that Pradaxa is a dangerous drug, mostly due to the lack of a reversal agent. Hundreds of Pradaxa lawsuits have been filed. In fact, so many Pradaxa lawsuits have been filed that the court system has resorted to a process called a multidistrict litigation, or MDL, to coordinate them.

The Pradaxa MDL is In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation, MDL No. 2385, in the United States District Court for the District of Illinois.