Pradaxa gastrointestinal bleeding is a serious complication patients can potentially develop when taking the new generation anticoagulant.

The popular blood thinner is typically prescribed to patients suffering from atrial fibrillation and are at high risk for stroke. However, injury reports of Pradaxa gastrointestinal bleeding have caused major concern in the patient population and medical community.

Pradaxa is a part of the anticoagulant class “direct thrombin inhibitors,” which prevents the clotting enzyme thrombin from working. This ultimately prevents blood from clotting, reducing the formation of blood clots.

However, this treatment mechanism also prevents the body from recovering from Pradaxa gastrointestinal bleeding, making the patients seek emergency medical treatment.

Pradaxa gastrointestinal bleeding has been linked to as many as 260 deaths since its approval, with numerous studies suggesting the drug increases the risk of internal bleeding. For example, one study analyzed bleeding incidents associated with Pradaxa gastrointestinal bleeding and reported the following statistics:

• 16.6% of Pradaxa internal bleeding incidents
• 3.3% of Pradaxa serious bleeding incidents
• 1.5% of Pradaxa life threatening bleeding incidents
• 0.3% of Pradaxa brain hemorrhage or stroke incidents

Pradaxa gastrointestinal bleeding risk is even greater in elderly patients with kidney problems, because the drug is directly processed the kidneys. In addition, Pradaxa gastrointestinal bleeding may be more likely for patients taking medications like NSAIDs that are linked to internal bleeding complications.

Overview of Pradaxa Gastrointestinal Bleeding Complications

When Pradaxa was first introduced to the United States in 2010, it was intended to be a direct competitor to warfarin. Pradaxa was the first medication released for blood thinning purposes since warfarin in the 1950s, and it quickly overtook the initial anticoagulant in popularity for its once-daily dosing convenience.

Warfarin patients had to undergo frequent doctor appointments for dose adjustments and prevention of internal bleeding events. However, critics say the lack of dose regulation may have contributed to the numerous Pradaxa gastrointestinal bleeding injuries, which can be potentially fatal.

In addition, warfarin was initially the only anticoagulant with an available reversal agent to resolve internal bleeding incidents. It wasn’t until about five years after Pradaxa was released that an antidote was finally made available that could reduce Pradaxa’s anticoagulant effect.

Accroding to a report by the Institute for Safe Medication Practices, over 307 Pradaxa internal bleeding reports were submitted to the FDA during the first three months the drug was on the market. This surpassed 98.7% of the other drugs monitored by the organization and is 50% more than injuries reported in conjunction with warfarin.

The FDA issued a public warning in December 2011 regarding Pradaxa internal bleeding complications, after reviewing post-market adverse event reports. Pradaxa patients who begin experiencing unexplained symptoms like unusual bruising or bleeding or bleeding in gums, may be at risk of uncontrollable internal bleeding death.

Patients who experience Pradaxa gastrointestinal bleeding problems may benefit from a consultation with a knowledgeable products liability attorney to get a good idea of their legal rights and options.