Side effects of Pradaxa remain a major concern for some patients in the United States, even though Boehringer Ingelheim had settled over 4,100 claims in 2014 for $650 million.

Patients continue to report side effects of Pradaxa, including incidents of uncontrollable bleeding. Despite the settlement, litigation will most likely continue against the company. Side effects of Pradaxa have been well documented since the drug’s release in 2010.

Pradaxa was the first medication to be released for anticoagulant treatment purposes since warfarin in the 1960s. Pradaxa is often prescribed to patients suffering from atrial fibrillation and who are at high risk for stroke. The drug works by preventing the formation of blood clots.

The release of Pradaxa opened the gateway for other pharmaceutical companies to try their hand in the anticoagulant market, with Xarelto and Eliquis released in the following two years.

Pradaxa and other anticoagulants work by shutting down the body’s clotting mechanism and increasing the efficiency of the body’s circulation system. However, this also inhibits the body’s self recovery ability in cases of internal bleeding.

This means that minor internal bleeding incidents can quickly turn fatal if emergency treatment is not implemented. Due to the serious risk of uncontrollable internal bleeding, patents are advised to look out for the following symptoms:

• Unusual Bruising or Bleeding
• Pink or Brown Urination Color
• Red or Black Tarry Stool
• Coughing up Blood
• Headaches, Dizziness, or Fatigue
• Gums Bleeding
• Frequent Nose Bleeds
• Weakness and Swelling in Arms and Legs

Overview of the Side Effects of Pradaxa

Even though the side effects of Pradaxa put patients at risk for uncontrollable internal bleeding, a reliable bleeding antidote was not released until 2015, when Boehringer Ingelheim received FDA approval for Praxbind.

However, the risk of potentially fatal internal bleeding complications remains a concern for Pradaxa patients. When Pradaxa was initially released in the United States, it was marketed as more convenient than warfarin.

In contrast to warfarin, Pradaxa can be prescribed in a single daily dose. Marketing touted its convenience compared to the constant dose adjustments required of warfarin patients. However, critics say that more frequent medical monitoring would help prevent incidents of potentially fatal bleeding.

According to the FDA, the agency received 307 injury reports of Pradaxa bleeding incidents during the first three months the drug was on the market. In addition, there were over 260 deaths allegedly caused by Pradaxa internal bleeding, later spurring the FDA to release a public warning regarding the risk in December 2011.

Even with this warning, patients are advised to be wary against the side effects of Pradaxa including:

• Internal Bleeding
• Kidney Bleeding
• Gastrointestinal Bleeding
• Heart Attack
• Stroke
• Brain Hemorrhage
• Death

Even though the risk of fatal internal bleeding incidents were potential side effects of Pradaxa, Boehringer Ingelheim allegedly failed to warn the general public. A class action investigation was sparked by the numerous injury reports helping many consumers seek compensation for their injuries.

Pradaxa patients who have suffered uncontrollable internal bleeding complications from the drug’s treatment mechanism may also be eligible to file legal action.