Pradaxa, generically known as dabigatran is a popular anticoagulant prescribed to prevent stroke and systemic blood clots in patients diagnosed with atrial fibrillation.

The medication is also sometimes prescribed to prevent risks of deep vein thrombosis and pulmonary embolism. Pradaxa was approved by the FDA back in 2010.

Since its approval, Pradaxa has been advertised as a superior alternative to other more traditional blood thinning medications. Pradaxa belongs to a new generation of blood thinners known as thrombin inhibitors.

Unlike more traditional medications, thrombin inhibitors do not require patients to follow strict dietary restrictions or undergo constant blood monitoring.

However, until recently no FDA approved Pradaxa reversal agent existed. Only patient’s taking Warfarin or Coumadin could be given an antidote if they began to suffer uncontrolled bleeding.

The antidote for warfarin is a dose of vitamin K mixed with fresh or frozen plasma. The anti-clotting agents in Pradaxa are so powerful that the anticoagulant effects cannot be undone without an antidote, even if the patient is given a blood transfusion.

What is the Pradaxa Reversal Agent?

In October of 2015, the US Food and Drug Administration (FDA) granted approval for the Pradaxa reversal agent known as Praxbind. The drug is administered to patients who are taking Pradaxa and later begin to experience uncontrolled bleeding side effects.

According to Dr.Richard Pazdur, a director of the office of Hematology and Oncology Products in the FDA, Praxbind is an important tool for managing patients taking Pradaxa in emergency or life threatening situations where the patient is experiencing uncontrolled bleeding.

Prior to its approval, the Pradaxa reversal agent, Praxbind, was tested in three separate trials which involved a total of 283 healthy volunteers (or volunteers who did not need an anticoagulant).

Another trial tested the medication on patients who needed a Pradaxa reversal agent due to uncontrolled bleeding. Praxbind was approved under the FDA’s accelerated approval program. This program is for medications and drugs that fill an unmet serious medical need.

Praxbind is now available for patients in over 2,200 hospitals across the United States. An online Praxbind locator site is now available to help healthcare professionals and patients find locations that stock the reversal agent.

Pradaxa Lawsuits

Although Pradaxa currently has an available antidote, prior to 2015 many patients suffered serious side effects from uncontrolled bleeds. Pradaxa lawsuits against Boehringer Ingelheim Pharmaceuticals may allege the company violated consumer protection laws.

Specific allegations may include failure to warn, negligence, breach of warranty, and misrepresentation. Plaintiffs who bring successful lawsuits may receive monetary compensation for their pain and suffering along with their past and future medical bills.

Lawsuits like these also help to hold pharmaceutical manufacturers accountable for their actions and to their consumers. These lawsuits can serve as a reminder that companies owe their consumers a specific duty of care.