Numerous patients have reported bleeding while on Pradaxa, which has resulted in numerous emergency room visits and several deaths. Patients who experience bleeding while on Pradaxa can now receive the recently approved reversal agent Praxbind, but that was not the case for the first five years the drug was on the market.

Manufacturer Boehringer Ingelheim has faced years of legal proceedings over the adverse effects of Pradaxa accused of failing to warn patients against potentially fatal internal bleeding.

The FDA issued a public safety warning in 2011 to the general public and medical community, stating uncontrollable internal bleeding may be a risk for Pradaxa patients. The FDA issued this warning after reviewing a post market study, with the agency stating it wanted to determine if Pradaxa was unreasonably dangerous to patients.

Before the FDA warning was released, the Institute for Safe Medication Practices (ISMP) found that over 307 Pradaxa injury reports were filed to the FDA within the first three months of being on the market. This surpassed 98.7% of all other medications being monitored by the ISMP at the time, exceeding warfarin injury reports by 50%.

In addition, over 260 deaths were reported in alleged conjunction of bleeding while on Pradaxa including incidents of gastrointestinal bleeding, hemorrhage, and stroke.

Overview of Pradaxa Bleeding Problems

Pradaxa was approved by the FDA in 2010 and was the first drug to be approved for anticoagulant purposes since warfarin in the 1950s, and is often prescribed to patients suffering from atrial fibrillation or are at high risk of blood clot attacks.

Pradaxa and other anticoagulants work by inhibiting the body’s clotting mechanism, which eases overall circulation. However, this treatment mechanism also prevents the body from being able to recover from minor internal bleeding injuries that can quickly become fatal.

When Pradaxa was first released onto the market, Boehringer Ingelheim marketed the drug for its efficiency and convenience. Unlike warfarin, Pradaxa and other new generation anticoagulants can be prescribed in a single dose prescription and do not need frequent adjustments by a physician.

However, warfarin was also the only anticoagulant to have a bleeding antidote for many years, with Praxbind just released in 2015.

Even though bleeding while on Pradaxa can be potentially fatal, Boehringer Ingelheim allegedly failed to warn patients against this possibility. Patients who experience bleeding while on Pradaxa should go to the emergency room as soon as possible, and should be vigilant for any signs including:

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

Boehringer Ingelheim has already had to settle millions of dollars in Pradaxa bleeding lawsuits, but is most likely going to continue to face legal action for some time.

Patients who experienced bleeding while on Pradaxa may be eligible for their own claim, and might be eligible to seek compensation for medical care. Injuries Pradaxa patients have filed legal action for include, but are not limited to:

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