Patients have reported problems with Pradaxa since its release in 2010, with numerous injury reports indicating uncontrollable internal bleeding incidents.

The problems with Pradaxa allegedly stem from the anticoagulant’s treatment mechanism, which inhibits the body from being able to recover from minor internal bleeding injuries.

While this is a risk with any anticoagulant, the problems with Pradaxa became widely publicized because at the time Pradaxa became available, there was no reversal agent in the case of internal bleeding events. Even with the release of Praxbind in 2015, patients still face a risk of internal bleeding.

Reversal agents are implemented to spur the body’s clotting mechanism and are vital for patients on anticoagulant treatment regiments. However, Pradaxa did not get a bleeding antidote until about five years after its release, which has put intense scrutiny on Boehringer Ingelheim.

Pradaxa was the first medication to be released for anticoagulant purposes since warfarin in the 1960s and was marketed to be more efficient and convenient than its predecessor. In contrast to the older anticoagulant, Pradaxa could be prescribed in a single dose and did not require frequent doctor appointments for dose adjustments.

However, without a bleeding antidote, Pradaxa’s dangerous side effects became apparent very quickly after its release. Complications reported in conjunction with Pradaxa use include, but are not limited to:

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

Overview of the Problems with Pradaxa

Pradaxa is often prescribed to patients suffering from atrial fibrillation, who are at high risk for blood clot injuries like stroke. Pradaxa and other anticoagulants work by preventing blood clots from forming.

Even with Pradaxa’s treatment mechanism, this medication has allegedly put numerous patients at risk due to potentially fatal uncontrollable bleeding complications.

According to the FDA, the agency had received 307 injury reports during the first three months the drug was on the market. The Pradaxa complications reported included internal bleeding gastrointestinal bleeding, with over 260 deaths reported during its first year.

In December 2011, the FDA issued a public warning stating that Pradaxa could induce potentially fatal internal bleeding and patients should be wary of any unusual symptoms including:

• Unusual Bruising or Bleeding
• Pink or Brown Urine
• Red or Black Tarry Stool
• Coughing up Blood
• Headaches
• Lethargy
• Bleeding from Gums
• Frequent Nose Bleeds
• Weakness and Swelling in Arms and Legs

These serious problems with Pradaxa often force the patient to undergo emergency hospital treatment. Even though Pradaxa internal bleeding complications are potentially fatal to patients, thousands of patients have claimed Boehringer Ingelheim failed to properly warn them about these dangers.

Numerous patients have opted to file legal action against the pharmaceutical giant for failing to warn them against these possibilities. Patients and their loved ones could potentially be compensated for any medical bills incurred from these problems with Pradaxa.