Since Pradaxa (dabigatran) was approved by the U.S. Food and Drug Administration (FDA) in 2010, there have been a multitude of reports filed about the results of Pradaxa bleeding risk. Reports of Pradaxa bleeding risk have raised questions about blood thinner safety.

A current Pradaxa internal bleeding class action lawsuit is actively researching patient claims from those injured by the anticoagulant medication.

Some conditions reported in association with Pradaxa bleeding risk include internal bleeding, kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhage, and death.

Pradaxa Bleeding Risk

Pradaxa is a relatively new anticoagulant which is manufactured by Boehringer Ingelheim Pharmaceuticals. It is prescribed to reduce the risks of developing blood clots and strokes. The drug is categorized in a class of drugs called direct thrombin inhibitors. Direct thrombin inhibitors limit thrombin, a principal enzyme that helps the blood clot.

Pradaxa, after its approval by the FDA, was marketed as a superior anticoagulant medication to another drug, warfarin (Coumadin), also on the market. Warfarin required constant monitoring and a change of diet, but patients prescribed Pradaxa required less monitoring and little or no change of diet.

However, in the case of accidental uncontrollable bleeding, warfarin had a reversal agent that could reverse the effects of the anticoagulant medication. Praxbind, Pradaxa’s reversal agent, was not made available to patients until Oct. 16, 2015.

Doctors of users of warfarin could counteract anticoagulant side effects such as abdominal bleeding by administering vitamin K. This causes internal bleeding to stop by allowing patients’ blood to clot normally once again.

No similar solution was made for Pradaxa patients. It was not until five years after Pradaxa’s approval in 2010 that Praxbind (idarucizumab) became approved as Pradaxa’s reversal agent.

In fact, in just the first three months of Pradaxa’s approval, the FDA received 307 Pradaxa bleeding reports. The reports involved serious health complications such as gastrointestinal bleeding and internal bleeding. Additionally, 207 death reports were made allegedly a result of Pradaxa’s hemorrhage, stroke, gastrointestinal bleeding, and internal bleeding side effects.

The FDA, in 2011, issued a safety warning announcement advising Pradaxa patients about serious internal bleeding side effects. Some symptoms of Pradaxa bleeding risk complications may include the coughing of blood, bleeding from the gums, frequent nose bleeds, vomiting blood and red or black stools.

Lawsuits being filed against the manufacturers allege that the issue with Pradaxa has been that there was no way, during the time prior to Praxbind’s approval, to stop Pradaxa bleeding risk.

The only way to stop Pradaxa’s anticoagulant effect was to flush it from the body using dialysis. This may take hours, cause a patient to undergo several blood transfusions and even result in their death.

Allegations against the company allege that although there are bleeding side effects that can result from all blood thinning and anticoagulant medications, Pradaxa is believed to cause increased life-threatening bleeding side effects that are much more dangerous.

Thousands of Pradaxa lawsuits have been filed against the manufacturer accusing them of having known about the severe side effects of the medication but failing to notify prescribing physicians and patients of such risks.