The blood thinning drug Pradaxa was the first medication to be approved for anticoagulant treatment purposes since warfarin in the 1950s. Pradaxa was approved by the FDA in 2010, with new generation anticoagulants Xarelto and Eliquis following not long after.

The blood thinning drug Pradaxa is manufactured by Boehringer Ingelheim and has earned the company millions, but has also landed the business in hot water over product liability claims. When Pradaxa first entered the market in 2010, it was touted as superior to warfarin for its efficacy and convenience.

Unlike warfarin that required frequent dose adjustments and doctor appointments, the blood thinning drug Pradaxa could be prescribed in a single dose. This made Pradaxa very convenient compared to its older competitor, which spurred numerous prescriptions to be written almost as soon as it was released.

However, the blood thinning drug Pradaxa lacked a vital safety feature warfarin had to combat cases of internal bleeding. Internal bleeding is a serious risk during anticoagulant treatment because the drug hampers the body’s clotting mechanism.

The idea behind this treatment mechanism is to prevent potentially fatal blood clot attacks. However, the body becomes vulnerable to uncontrollable internal bleeding incidents because the recovery mechanism is disabled.

While warfarin patients have the readily available vitamin K in case this happens, Pradaxa patients only recently got an approved bleeding antidote approved. The antidote Praxbind was approved by the FDA in 2015, and can be administered during emergency medical intervention of an internal bleeding event.

While Boehringer Ingelheim did successfully release a reversal agent for the blood thinning drug Pradaxa, the company allegedly failed to warn patients against potentially fatal internal bleeding.

Overview of Pradaxa Bleeding Complications

According to the Institute for Safe Medication Practices (ISMP), over 307 injury reports were submitted to the FDA during the first three months the blood thinning drug Pradaxa was on the market.

These reports surpassed 98.7% of other medications being monitored by the ISMP at the time. The FDA eventually issued a public safety warning regarding Pradaxa internal bleeding complications in December 2011, stating the general public and medical community should be aware of the potential problems.

While the FDA did note that potential uncontrollable internal bleeding was a risk with all anticoagulants, the FDA stated it was investigating whether or not Pradaxa carried a higher risk. Patients prescribed the blood thinning drug Pradaxa should be aware of signs or symptoms of internal bleeding including:

• Unusual bruising or bleeding
• Pink or brown urine
• Red or black stool
• Coughing up blood
• Headaches or dizziness
• Fatigue or lethargy
• Bleeding from gums or frequent nose bleeds
• Weakness and swelling in arms and legs

Pradaxa patients who experience these or other unusual symptoms should seek medical help immediately, and call their doctor if they have any questions about drug complications. Even though potentially uncontrollable internal bleeding can be fatal, Boehringer Ingelheim allegedly failed to warn patients against this risk.

Numerous patients who suffered complications relating to the blood thinning drug Pradaxa have filed legal action against the company, with Boehringer Ingelheim already paying out millions in settlements.