Pradaxa reportedly had 3,781 cases of reported Pradaxa adverse effects events reported between the U.S. Food and Drug Administration (FDA), health professionals, databases, and the manufacturers in its first year on the market. Among those documented Pradaxa adverse effects events are 542 instances in which Pradaxa was suspected of causing the patient’s death.

Pradaxa, known genericaly as dabigatran, was approved by the FDA in the fall of 2010 as a prophylactic or preventative treatment for stroke in patients with atrial fibrillation, and to treat or prevent deep vein thrombosis (DVT), pulmonary embolism (PE), and the creation of blood clots after total hip or knee arthroscopy.

Blood clots are often produced after these highly-invasive surgical procedures. If they travel to the heart or lung region, they can produce cardiac or respiratory arrest.

The newer anticoagulants were created to compete with warfarin, the generic name for Coumadin, an anticoagulant that has been successfully used for around 60 years. The manufacturer, Boehringer Ingelheim Pharmaceuticals, attempted to set Pradaxa apart from warfarin by promoting that once a day dosing and a lack of dietary constraints during treatment made it different.

The promotions also underscored that the drug needed almost no monitoring. But patients who reported Pradaxa adverse effects events soon told a different story.

The Pradaxa adverse effects events revealed numerous cases of uncontrolled internal bleeding focused on the gastrointestinal area, kidney area, and even the brain. Unlike with warfarin, where a rapid infusion of vitamin K could bring the bleeding and clotting factors back under control if discovered in time, Pradaxa had no such antidote to its blood-thinning tendencies for its first several years on the market.

Praxbind, a Pradaxa antidote that can help get bleeding under control, was approved by the FDA in October 2015. For many patients who already experienced Pradaxa adverse effects, it came a little late. While the FDA issued a warning in 2011 about experiences of internal bleeding related to the drug, many suffered and there were alleged deaths.

Several individual Pradaxa lawsuits have been filed since then against Boehringer Ingelheim Pharmaceuticals. Plaintiffs in these lawsuits accuse the company of misleading the public by overstating the safety and reliability of the drug while failing to warn potential patients and the prescribing medical community. Plaintiffs argue it was unsafe to release a medication of this nature without a known antidote.

What are the Signs and Symptoms of Internal Bleeding?

Pradaxa adverse effects events were often shaped by the fact that they were not caught early. Signs and symptoms of internal bleeding can be varied, and medical treatment should be sought immediately. Some of these are:

• Bruising without apparent cause
• Coughing up Blood or What Appears to be Coffee Grounds
• Red or Black Stools
• Bleeding Gums
• Different-Colored Urine
• Nose Bleeds
• An Unusually Heavy Period (in Women)

If you or a loved one experienced any of these symptoms while taking Pradaxa, you may have a legal claim.