Pradaxa® May Cause Uncontrollable Internal Bleeding in Some Patients

circulatory systemA popular blood-thinning medication, Pradaxa (dabigatran etexilate mesylate), is produced by Germany's second-largest pharmaceutical manufacturer, Boehringer Ingelheim. The U.S. Food and Drug Administration (FDA) approved Pradaxa in 2010 to prevent blood clots and strokes in patients with abnormal heart rhythm or atrial fibrillation. It quickly became one of the most-prescribed drugs in its class, with sales topping $1.2 billion in 2014 as patients and doctors alike responded to the medication's claims of greater efficacy and convenience compared to older anticoagulants.

However, recent studies linking Pradaxa to serious—and even deadly—internal bleeding events have led many patients taking Pradaxa to question if use of the drug is right for them. Read on to learn more about Pradaxa and Pradaxa-related internal bleeding complications, as well as what you can do if you or someone you love experienced uncontrollable bleeding while on Pradaxa. 

How Pradaxa Works

Pradaxa was the first drug in a new class of anti-clotting medications known as novel oral anticoagulants (NOACs), which also includes Eliquis® (made by Pfizer and Bristol Myers-Squibb) and Xarelto® (made by Bayer).

While blood-thinners such warfarin prevent blood clots and strokes by reducing vitamin K levels in the blood, Pradaxa achieves the same goal through entirely different means. Rather than decreasing vitamin K, anticoagulants like Pradaxa inhibit the clotting enzyme thrombin, which prevents platelets from sticking together to form clots. Also, unlike patients who take warfarin, patients taking Pradaxa aren't required to avoid foods high in vitamin K or submit to regular blood tests and other monitoring.

Signs and Symptoms of Pradaxa-Related Internal Bleeding

Not all patients who take Pradaxa will experience serious or uncontrollable internal bleeding. However, those who do can increase their chances of survival by seeking immediate medical attention at the first sign of symptoms. Contact your doctor right away if you experience any of the following:

  • Excessive or unexplained bruises
  • Swollen or painful joints
  • Weakness or fainting
  • Bloody urine or stools
  • Small red or purple spots under the skin
  • Coughing fits that produce blood, vomit or a substance that looks like coffee grounds
  • Unusually heavy menstrual bleeding
  • Abnormal bleeding from the nose, mouth, vagina, or rectum

Praxbind Antidote

Some people may be shocked to discover that uncontrollable internal bleeding is the leading cause of death for patients taking Pradaxa. This may have something to do with the fact that, from 2010 to 2015, there wasn't an FDA-approved antidote for the drug. Internal bleeding in warfarin patients could be corrected by administering vitamin K, but there wasn't a safe or reliable way to stop uncontrollable or internal bleeding in Pradaxa patients.  The best doctors could do was send their patients to dialysis in an attempt to “clean” the drug from the bloodstream. Unfortunately, this approach was hit or miss, as dialysis was only capable of removing up to 60 percent of the medication. This inability to reverse Pradaxa's blood-thinning effects ultimately led to more than 500 internal bleeding deaths.

In response to widespread reports of bleeding incidents, and an outcry from patients and doctors, the FDA fast-tracked approval of Boehringer Ingelheim's Praxbind® Pradaxa antidote in October 2015. Praxbind works by binding to the dabigatran and acylglucuronide metabolites in Pradaxa and immediately neutralizing their effects, without having an effect on other forms of anticoagulants or antithrombotics. The antidote can be used to reverse the effects of any NOAC drug.

Did You Experience Internal Bleeding While Taking Pradaxa?

If you experienced a serious internal bleeding event while taking Pradaxa, or lost a loved one to Pradaxa-related uncontrollable bleeding, you may be able to pursue compensation from the drug's manufacturer, Boehringer Ingelheim. A fair financial award can help Pradaxa patients pay their medical bills and compensate them for physical pain, emotional suffering, and more. Contact McGartland Law today to schedule an appointment for a free initial consultation to discuss the details of your potential Pradaxa personal injury or wrongful death case. McGartland Law has more than 30 years of experience and handles injury cases from across the country.