Dabigatran, the generic name for Pradaxa, is a blood-thinning medication brought to the commercial marketplace in the fall of 2010.

Unlike the long-standing anticoagulant warfarin, sold as the drug Coumadin, Pradaxa dangers like out-of-control gastrointestinal and other internal bleeding initially had no antidote that could help get them under control.

While all drugs with blood-thinning properties come with associated inherent risks, analysis usually shows that the benefits in preventing Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and strokes secondary to the weakened heart condition known as atrial fibrillation are greater than the dangers. But critics of Pradaxa say that reports of bleeding side effects are too numerous for this medication to be considered safe.

Praxbind, the antidote for Pradaxa, was not approved until October 2015—five years after the release of dabigatran. During those five years, there were many reported injuries related associated with this and other drugs of the New Oral Anticoagulant (NOAC) class.

In just the first quarter after its sales began, alleged evidence of Pradaxa dangers was reported to the U.S. Food and Drug Administration (FDA). The FDA maintains a database of dangerous experiences related to drugs known as the FDA Adverse Event Reporting System (FAERS).

FAERS supposedly received over 300 notifications of bleeding issues and other complications related to dabigatran in those initial three months.

Not only were Pradaxa dangers evident in this database from its marketplace launch, the first year revealed other alarming data: close to 300 cases of gastrointestinal and internal bleeding in Pradaxa patients resulted in death.

Pradaxa vs. Warfarin

The NOAC drug class, of which dabigatran or Pradaxa is one example, were made to compete with warfarin. Warfarin is a long-standing blood-thinner therapeutically in use for decades.

The creators of NOACs allegedly attempted to garner warfarin’s corner on this area of the pharmaceutical market by making the new drugs appear more convenient to take.

Since warfarin required frequent blood-monitoring to ensure that a therapeutic dosage level was maintained during treatment, the makers of Pradaxa—Boehringer Ingelheim—and other NOACs, emphasized that there was no such need when taking them.

Additionally, the medical professional community and public were told that dietary modifications were not necessary on NOACs like Pradaxa. Warfarin users had historically also been told to refrain from ingesting green, leafy vegetables high in vitamin K such as brussels sprouts, kale, spinach, and Swiss chard to keep from working at cross-purposes to the action of the drug.

Certain herbal supplements and these high-vitamin K leafy vegetables could thicken the blood.

Many patients who suffered excessive bleeding while on Pradaxa say they were not adequately warned that there was no antidote should situations of bleeding come up where a patient’s life was endangered. Medical professionals had known for decades that bleeding on warfarin could be brought under control with a rapid infusion of vitamin K, but that was not the case with the newer blood-thinners when they were introduced to the market.