Pradaxa (dagibatran) is one of several blood thinner medications classified as a new oral anticoagulant.

Pradaxa, along with Eliquis and Xarelto, have been released in the last several years as an alternative to warfarin, the most commonly used oral anticoagulant medication since the 1950s.

Patients and doctors alike were pleased to have these new alternative blood thinner medications enter the market, as they appeared to be just as effective as warfarin but with less monitoring required and no dietary restrictions needed with their use.

However, as with any prescription medication, Pradaxa adverse effects are experienced by users of the drug, and for some, the drug’s benefits did not outweigh the risks.

Pradaxa Adverse Effects

With any blood thinning medications, side effects are common. These include things like nausea and stomach pain or upset, heartburn, diarrhea or increased bruising and minor bleeding. Typically these side effects are minor and do not affect the patient’s treatment outcome in any way.

However, severe Pradaxa adverse effects are possible. Uncontrollable internal bleeding, particularly in the gastrointestinal tract as well as in the brain, is the most common of Pradaxa adverse effects.

With any blood thinning medication, internal bleeding is a risk simply because of the way the medication works.

Pradaxa blocks a protein in the body responsible for the clotting of blood. This works for its intended purpose of thinning blood to reduce the risk of clots and their sequelae such as stroke, heart attack and pulmonary embolism.

Counteracting Pradaxa Adverse Effects

For the first five years Pradaxa was on the market, there was no antidote to control the bleeding in patients once uncontrollable bleeding events started.

The best that could be done for these patients was to hospitalize them and attempt to stabilize them as the medication processed out of their body.

For some, irreversible damage was done, and for others little to no side effects occurred after the patient was stabilized. For others still, the outcome was unsuccessful, leading to fatalities.

With warfarin, the most commonly used oral anticoagulant drug before Pradaxa was released, an antidote existed if patients experienced uncontrollable bleeding.

Fresh frozen plasma and intravenous vitamin K could be administered to reverse the anti-clotting mechanism of the medication, thus restoring the body’s natural clotting mechanisms to stop the internal bleeding.

When Pradaxa was released, no such antidote existed. It wasn’t until late last year that an antidote was released onto the market to combat uncontrolled bleeding in patients using Pradaxa.

The antidote, known as Praxbind, is designed to counteract the blood thinning effects of Pradaxa, thereby restoring the natural mechanisms of the body.

Pradaxa Adverse Effects Lawsuits

These lawsuits similarly alleged that the manufacturer did not do enough to warn patients and physicians of the severe side effects, including death, that could result from the use of Pradaxa.

Without admitting fault, in 2014, Boehringer Ingelheim reached a settlement with the thousands of lawsuits that were pending at the time.

The settlements totaled $650 million with an individual payout of approximately $162,500 to each plaintiff.

Pradaxa uncontrollable bleeding lawsuits continue to be filed and have the same allegations. It is hoped that these lawsuits will soon taper off once patients are able to be treated with Praxbind.

However, for those patients and families who had to deal with Pradaxa adverse effects prior to the release of the antidote, a Pradaxa uncontrollable bleeding lawsuit may be the only way to recover damages from injuries due to internal bleeding events experienced by patients.