Pradaxa has been available for about eight years to treat those who were at risk for pulmonary embolism or deep vein thrombosis. However, the increased reports of Pradaxa complications, including Pradaxa deaths, have led to many filing lawsuits and the approval of a reversal agent, Praxbind.

Pradaxa, generically known as dabigatran, is a newer anticoagulant drug that was approved in 2010 by the Food and Drug Administration (FDA). Along with pulmonary embolism and deep vein thrombosis, Pradaxa has also been approved to treat patients with atrial fibrillation.

In the first year after it was approved, patients began experiencing excessive bleeding complications. In fact, there were several reports of Pradaxa deaths from uncontrollable internal bleeding as a result of the inability to stop a hemorrhage in a Pradaxa user.

In the first year of approval, approximately 260 Pradaxa deaths were reported to the FDA.

Pradaxa’s drug class is called Direct Thrombin Inhibitors. Direct Thrombin Inhibitors prevent the blood’s central clotting agent, thrombin, from forming clots. This reduces the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Deep vein thrombosis is when a clot forms deep in the veins of the lower extremities. This is dangerous because that clot can travel and move to the brain, heart or lungs.

Pulmonary embolism is when a blood clot travels to the lungs and blocks arteries in the lungs. Both conditions are potentially fatal, and Pradaxa is prescribed to many patients to prevent them.

However, patients who take Pradaxa are at risk of excessive bleeding. Not until recently has a reversal agent been approved by the FDA to combat the effects of uncontrollable bleeding in a Pradaxa user. These Pradaxa uncontrollable bleeding events have led to Pradaxa deaths over the several years it was approved without an antidote.

Pradaxa, along with other Direct Thrombin Inhibitors, was promoted as a superior alternative to the normally prescribed anticoagulant, warfarin. Warfarin, brand name Coumadin, has been prescribed to countless patients suffering from similar conditions such as risks of pulmonary embolism and deep vein thrombosis as well as atrial fibrillation.

Those who took warfarin are subject to dietary restrictions as well as constant dosage and blood monitoring. When Pradaxa was approved, drug manufacturers marketed their drug as superior to warfarin because patients did not need the same amount of monitoring, the dosage was one-size-fits-all and there was little need for dietary restrictions.

However, because of the nature of anticoagulants, patients have an increased risk of uncontrollable bleeding incidents. With warfarin users, a doctor needs only to administer vitamin K to reverse the effects of the blood thinning medication. With Pradaxa, there was no reversal agent for several years.

It was only recently that the FDA approved an antidote for Pradaxa: Praxbind. Praxbind reverses the effects of Pradaxa, but it was too late for some patients.

The loved ones of those who have died as a result of Pradaxa have filed lawsuits against the drugmaker regarding Pradaxa deaths. If you believe your loved one has died as a result of Pradaxa, you may benefit from speaking to an experienced attorney.