The blood thinning drug Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in the second half of the year in 2010. The anticoagulant’s manufacturer—Boehringer Ingelheim—pushed the drug through the approval process without having an antidote for the internal bleeding that can come as a side effect of most of these types of drugs.

The blood thinning drug Pradaxa—like Eliquis and Xarelto—are part of a class of drugs specifically created to compete with a long-standing anticoagulant which has had a corner on the market for decades. This medication class has come to be known as the New Oral Anticoagulants (NOACs).

Warfarin—the drug that NOACs were supposed to pull from its commercial perch–is sold under this generic name and also under the brand name Coumadin. It has been used for close to 60 years to prevent blood clots forming and traveling systemically in the body.

The conditions for which warfarin and, then later, the blood thinning drug Pradaxa were prescribed include deep vein thrombosis (DVT), and pulmonary embolism (PE). It is also used to reduce the chance of stroke in patients that have been diagnosed with a heart rhythm issue known as non-valvular atrial fibrillation.

The blood thinning drug Pradaxa was allegedly supposed to be superior, according to metrics established by Boehringer Ingelheim in their clinical safety trials. After its approval by the FDA, the pharmaceutical company set to aggressively advertising the anticoagulant by setting it apart from warfarin on the basis of dosage and diet.

Historically, warfarin has required close laboratory monitoring while a person is under treatment to ensure that she or he remains within a certain range for maximum effectiveness. For the outpatient, this means at least weekly or twice weekly trips to a hospital lab. Since most often this drug is prescribed post-operatively to total knee and hip replacement patients, this is not easy.

Warfarin also requires that the patient avoid green leafy vegetables that could be loaded with vitamin K. The reason for this is because vitamin K is an antidote to the anticoagulant properties.

So the makers of the blood thinning drug Pradaxa tried to establish in their promotion that their product needed to be taken only once a day, needed no lab monitoring, and that one needed not worry about making any changes to their food intake while on the drug.

Patients Allege Manufacturer Omissions

Many physicians started to prescribe the blood thinning drug Pradaxa after its approval, and in the first quarter of sales, over 300 serious medical incidents were reported involving the drug and intestinal or other internal bleeding. By the end of the first year of commercial availability, 260 deaths were reportedly associated with the anticoagulant.

While vitamin K-enriched foods need not be avoided, they also couldn’t be relied upon to reverse the bleeding that was occurring. Emergency rooms and medical teams were hard-pressed to come up with a solution to the adverse problems this NOAC presented.

Warfarin was a known quantity with a known reversal agent—rapid infusion of vitamin K. The blood thinning drug Pradaxa did not have an anditote when it was introduced, and it would remain on the market for a full five years before the FDA pushed Praxbind through the approval process out of pure necessity.

In the face of these alleged casualties and serious side effects, Boehringer Ingelheim allegedly did not make any attempt to pull Pradaxa from the market. If you or a loved one took the blood thinning drug and suffered intestinal or other internal bleeding, or you are a surviving spouse, you may have a legal claim.