Pradaxa is a blood thinner that was approved by the FDA in 2010, but allegedly is apt to produce uncontrollable bleeding than its biggest competitor, Coumadin.

Patients are prescribed blood thinners as a way to prevent blood clots, pulmonary embolisms, strokes, and to treat atrial fibrillation, among other circulatory issues.

In a study of more than 134,000 patients over age 65, Pradaxa users had an increased risk of major gastrointestinal (GI) bleeding than those who were taking Coumadin, generically known as warfarin.

Pradaxa Settles Lawsuits

Pradaxa’s parent company, Boehringer Ingelheim, has settled lawsuits in the hundreds of millions of dollars involving patients and their families who suffered ill effects of uncontrollable bleeding.

It paid $650 million to settle 4,000 lawsuits in May 2014 instead of standing trial in the US District Court for the Southern District of Illinois.

Although it had only been on the market for a year, more than 540 patients died in 2011 after they had used Pradaxa. And patients did not have to be on the blood thinner before too long before they started to experience serious bleeding issues.

One woman had to have a blood transfusion after being on Pradaxa for only one month back in 2011. She had been taking Pradaxa to treat her atrial fibrillation when within four weeks of treatment, she was hospitalized for GI bleeding.

A Wisconsin gentleman said he saw his sister die because of uncontrollable internal bleeding allegedly caused by Pradaxa side effects. Doctors were unable to help her.

Introducing Praxbind

Although Boehringer Ingelheim released Pradaxa to the public in 2010, it wasn’t until October 2015 that Praxbind became available.

Praxbind is an antidote to the bleeding effects of Pradaxa. In emergency situations or when surgeries could be necessary, doctors can administer a dose of Praxbind that can counteract the anticoagulant properties of Pradaxa. The FDA in recognizing the urgent need for the antidote granted Praxbind accelerated approval.

In releasing Praxbind, the FDA acknowledged that Pradaxa can lead to uncontrollable bleeding.

“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,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can’t be controlled.”

In an FDA laboratory trial of 123 patients who were taking Pradaxa, a dose of Praxbind fully reversed the Pradaza anticoagulant effect within four hours of 89 percent of the patients. Here is the full story on the FDA’s release of Praxbind.

Unfortunately, the arrival of Praxbind is too late for many patients and their families who have suffered the ill effects of hemorrhaging allegedly caused by Pradaxa.

Marketing Hid Pradaxa Internal Bleeding Risks

Boehringer Ingelheim allegedly failed to warn the public of the serious risks of Pradaxa side effects, and for the first several years, offered no solution for people who were suffering from severe internal bleeding.

A class action lawsuit could help injured parties and their loved ones recover money from medical expenses, lost wages, pain and suffering, and sadly, even funeral expenses associated with Pradaxa internal bleeding injuries.