Numerous Pradaxa patients have reported serious blood thinner side effects, which they say were not adequately mentioned on the medication’s warning label. The reported blood thinner side effects primarily pertain to severe internal bleeding incidents often requiring emergency medical intervention.

Since Pradaxa was approved by the FDA in 2010, it has been the subject of thousands of injury reports describing adverse blood thinner side effects. The FDA has reportedly received 3,781 injury reports describing serious internal bleeding injuries and 542 death reports in 2011.

In fact, within the first three months on the market, the FDA announced that it had received 307 injury reports of adverse blood thinner side effects, including incidents of gastrointestinal bleeding. Furthermore, over 260 deaths were reported within the first year the drug was the market. The deaths were allegedly being caused by internal bleeding, gastrointestinal bleeding, hemorrhage, and stroke.

These serious blood thinner side effects eventually spurred the FDA to issue a warning in 2011, stating that Pradaxa treatment could lead to uncontrollable internal bleeding.

The FDA issued an updated warning in November 2012, stating that recommendations for the blood thinner did not change but the agency is currently evaluating the risk of internal bleeding events.

The latest FDA warning issued over Pradaxa was issued in May of 2014. The federal agency warned that elderly patients had a lower risk of stroke with Pradaxa compared to warfarin, but faced a higher risk of gastrointestinal bleeding. Just a year later in 2015, Boheringer Ingelheim finally released Pradaxa’s long awaited bleeding antidote, Praxbind.

However, patients who took Pradaxa prior to the release of Praxbind say they were not warned about the serious risk of blood thinner side effects, including severe internal bleeding.

Overview of Blood Thinner Side Effects

Like other blood thinners, Pradaxa works by inhibiting the body’s clotting mechanism and increases efficiency in circulation. This prevents blood clot formation, making Pradaxa a good choice for atrial fibrillation and stroke prevention.

However, the treatment mechanism also reportedly inhibits the body’s recovery process for internal bleeding injuries — clotting. This causes minor internal bleeding to potentially become fatal, requiring emergency medical intervention to prevent death.

While all blood thinners carry this risk, uncontrollable internal bleeding is especially prevalent among new generation anticoagulants like Pradaxa. It is important to note that Pradaxa was the first medication to be approved for blood thinning treatment purposes since warfarin in the 1960s, with fellow new anticoagulants Xarelto and Eliquis following just years later.

The main difference between Pradaxa and warfarin is the newer drug’s convenient single dose prescription feature. In contrast, warfarin patients often had to undergo frequent doctor appointments for dose adjustments.

However, Pradaxa lacked an established reversal agent for internal bleeding for years, while warfarin patients were able to use vitamin K to reverse bleeding events. Even though these blood thinner side effects could be potentially fatal, Boheringer Ingelheim allegedly failed to warn patients against this for years and allegedly omitted the fact that there was no initial reversal agent.

For the first five years Pradaxa was on the market, patients say they were exposed to a higher risk of death from internal bleeding. Even with the approval of Praxbind, patients should still be wary of signs of internal bleeding including:

• Frequent Nose Bleeds
• Gums Bleeding
• Odd Colored Urine
• Red or Black Stools
• Coughing up Blood
• Vomiting Blood