Pradaxa bleeding problems have been a prominent concern for the medical community and patient population since the drug was first released in 2010. It is important to note that Pradaxa was the first medication to be used for anticoagulant treatment purposes since warfarin was released decades earlier.

In contrast to warfarin, Pradaxa could be prescribed in a single dose and seemed much more convenient than the older anticoagulant. Millions of Americans are prescribed Pradaxa and other anticoagulants to help prevent blood clot attacks and to aid those who suffer from atrial fibrillation.

Anticoagulants work by inhibiting the body’s clotting mechanism which increases the efficiency of circulation. However, this treatment mechanism also causes the body’s clotting mechanism to stop working, which makes patients vulnerable to uncontrollable and fatal internal bleeding incidents.

The bleeding incidents associated with Pradaxa include, but are not limited to:

• Internal bleeding
• Kidney bleeding
• Gastrointestinal bleeding
• Heart attack
• Stroke
• Brain hemorrhage
• Death

Another difference between warfarin and Pradaxa is that the older anticoagulant has an established bleeding antidote in the form of vitamin K. However, Pradaxa did not get an approved bleeding antidote, Praxbind, until 2015.

Overview of Pradaxa Bleeding Complications

According to the FDA, the agency had received 307 injury reports of serious Pradaxa bleeding problems within the first three months of the drug being on the market. The complications in the first year reportedly included internal and gastrointestinal bleeding problems and 260 reported deaths.

According to 2010 QuarterWatch report from the Institute for Safe Medication Practices (ISMP), the FDA had reportedly received a number of “early” injury reports allegedly caused by Pradaxa. The ISMP study found that hemorrhages were the most prominent injuries and that this medication carried a high risk compared to other anticoagulants.

These Pradaxa bleeding problems eventually spurred the FDA to issue a warning in December 2011, stating patients should be aware of possible uncontrollable internal bleeding that could be caused by the medication.

Patients are currently being advised to follow their prescription instructions carefully and to report any side effects to their doctors. Signs and symptoms of internal bleeding include, but are not limited to:

• Frequent nose bleeds
• Bleeding from gums
• Discolored urine
• Red or black stool
• Coughing up blood
• Vomiting blood

Boehringer Ingelheim manufactures Pradaxa, and has received massive financial success for breaking into the lucrative anticoagulant market. However, the company has faced serious public scrutiny for allegedly failing to warn the general public about Pradaxa bleeding risks.

Dozens of Pradaxa lawsuits have been filed against Boehringer Ingelheim, alleging the company did not disclose this information on the drug’s warning labels or marketing materials. The company recently paid $650 million to settle 4,000 Pradaxa lawsuits, which consisted of patients alleging negligence and failure to warn.

Pradaxa patients who suffered unexpected bleeding complications may be able to file legal action against Boehringer Ingelheim. Potential claimants could seek potential compensation for any medical damages, including any hospitalization that was required to stop the uncontrollable internal bleeding.