The popular, new generation anticoagulant Pradaxa (dabigatran) has come under fire in the last couple years for its link to uncontrollable bleeding events.

However, according to recent reports, a reversal agent for this blood thinner may be on the horizon.

According to recent news, Pradaxa drug maker Boehringer Ingelheim has presented results from a Phase 3 RE-VERSE AD study that state five grams of idarucizumab administered to a patient on Pradaxa would allow doctors to perform emergency surgery without the risk of the patient bleeding out during the procedure.

This is good news for Pradaxa patients, as many taking this anticoagulant experience complications, including:

• Internal bleeding
• Kidney bleeding
• Gastrointestinal bleeding
• Heart attack
• Stroke
• Brain hemorrhage
• Death

History of Pradaxa Complications

Pradaxa was first approved for use as a blood thinner by the FDA in 2010, and was one of the first new generation anticoagulants approved within the United States since Warfarin (Coumadin). This Boehringer Ingelheim pharmaceutical drug is part of class of drugs known as Direct Thrombin Inhibitors.

According to the manufacturers marketing for the drug, Pradaxa is allegedly superior to the traditional Warfarin, as it supposedly does not require strict monitoring or diet changes.

However, it is important to note that when Pradaxa was approved for use, Boehringer Ingelheim had not created a bleeding reversal agent to combat incidences of uncontrollable internal bleeding.

This is one area in which Warfarin has an edge over its newer counterparts; if a patient experiences a bleeding event while taking Warfarin, they can be administered a dose of Vitamin K to counter the effects of the blood thinner and avoid injury.

Just three months after being approved for sale on the American pharmaceutical market, 307 adverse event reports were filed to the FDA regarding Pradaxa injuries and within the first year, the agency received 260 reports of death stemming from Pradaxa bleeding complications.

Possible Pradaxa Antidote

Pradaxa’s manufacturer recently conducted RE-VERSE AD, which is a Phase 3 global study with the goal of finding a suitable Pradaxa reversal agent. The study included patients using Pradaxa who experienced life-threatening bleeding or were required to undergo emergency surgery while on the blood thinner.

An emergency surgery, according to the study’s definition, is a surgical or invasive procedure that cannot be delayed for more than eight hours.

According to the data collected by the study, the median time between the administration of the potential reversal agent idarucizumab and the start of the emergency surgery was 1.7 hours.

During these surgeries, doctors reported the Pradaxa patients exhibited normal blood clotting 92 percent of the time; furthermore there were no post-surgical reports of bleeding complications 24 hours after the procedure.

Because idarucizumab was able to quickly and effectively reverse the effects of Pradaxa, this may mean that a reversal agent may soon be on the market to help avoid serious or life-threatening injuries.

Pradaxa Lawsuits

While the announcement of the possible antidote is great news for current and future Pradaxa users, it does not solve the injuries already incurred by patients on Pradaxa since 2010, or bring back those who have died from the medication. As a result, many patients or their family members are now filing Pradaxa lawsuits against the manufacturer.