Some Pradaxa internal bleeding complications occurring in the first five years the anticoagulant medication was commercially available might have been avoidable. According to some patients, the drug’s manufacturer Boehringer Ingelheim allegedly neglected to properly disclose  the fact that there was no antidote for Pradaxa internal bleeding complications ready and available.

Pradaxa internal bleeding complications were not substantially different from those of any other blood-thinning medication. A risk of out-of-control bleeding within the body goes hand-in-hand with attempting to thin the blood to prevent blood clots that can travel to and obstruct the life support activities of the heart, lungs, and brain.

Warfarin, the anticoagulant that Pradaxa was developed to compete with, also can bring on these episodes, despite its use being established over several decades.

The difference is that it is well-known that warfarin bleeding can be brought under control by infusing the patient with vitamin K. In fact, the knowledge that vitamin K counteracts the activity of warfarin is so ubiquitous that patients are advised to avoid green leafy vegetables and other foods that are high in this nutrient during treatment such as:

• Spinach
• Brussel Sprouts
• Asparagus
• Soybeans
• Edamame
• Collard Greens
• Blueberries
• Pine Nuts
• Turnip Greens
• Lettuce
• Pickles
• Sauerkraut
• Kale

Patients allege that because Pradaxa internal bleeding complications had no known or convenient remedy in the drug’s early years, serious and fatal consequences ensued. Reports of these complications actually numbered 300 in just the first quarter after the blood-thinner was FDA approved.

By the end of 2011, the first year of sales, 260 fatal incidents of Pradaxa internal bleeding complications were registered with the federal drug oversight agency.

Thousands of patients have alleged the manufacturer failed to properly address these Pradaxa internal bleeding complications. There was allegedly no attempt to adjust or recall the product in the face of these statistics.

No remedy was forthcoming from Boehringer Ingelheim until a full five years after Pradaxa’s market introduction and, when it was made ready, the FDA had to push it through the approval process faster than normal to add a measure of safety to the much advertised drug.

For the families of those who died as a direct consequence of Pradaxa internal bleeding complications, the delayed presence of Praxbind—Pradaxa’s delayed remedy—did little to comfort.

Why are Blood-Thinners Prescribed?

Blood-thinning medications were historically prescribed to prevent blood clot injuries like Deep Vein Thrombosis (DVT)—a condition inherent in some people where they produce blood clots in the lower extremities.

These blood clots can break off and freely move and obstruct the heart, lungs, and brain. When a clot gets lodged in the lungs, it is referred to as a Pulmonary Embolism (PE). When a clot travels through a carotid artery to the brain, it can cause a stroke.

The FDA-approved uses of warfarin and all later developed New Oral Anticoagulants (NOACs), which include Pradaxa, Eliquis, and Xarelto, were later expanded to include patients who were at short-term risk of developing these conditions. Among those are people undergoing cancer treatment and total hip and knee replacements.

Were you or a loved one prescribed Pradaxa for any reason and suffered out-of-control internal bleeding in the gastrointestinal tract, brain, kidneys or elsewhere? Did your loved one pass away from Pradaxa internal bleeding complications? You may have a legal claim. Fill out the form on this page to request a legal consultation.