Internal bleeding from Pradaxa may be difficult or impossible to get under control.

Pradaxa, or dabigatran as it is known generically, was approved by the U.S. Food and Drug Administration (FDA) in the fall of 2010. Within its first fiscal quarter on the market, it was the subject of over 300 adverse medical event complaints involving internal bleeding from Pradaxa.

Patient advocates argue that internal bleeding from Pradaxa could have been remedied quickly if the drug’s manufacturer Boehringer Ingelheim had provided an antidote to its blood-thinning properties. All of the NOACs were created to compete commercially with warfarin, a go-to blood thinner which has been successfully used for six decades.

The known antidote for warfarin is a rapid intake of vitamin K. Vitamin K is found in green leafy vegetables such a kale, spinach, collard greens and romaine. It is also found in vegetables such as brussel sprouts, cauliflower cabbage, and broccoli.

Dabigatran was aggressively marketed and promoted upon its commercial approval as an alternative to warfarin because it could be taken only once per day and because no dietary changes were needed to ensure its effectiveness. If foods with lots of vitamin K were and are an antidote to warfarin’s blood-thinning properties, they were also the type of nutrition that a patient needed to avoid, since they can counteract warfarin’s anticoagulant effect.

The problem with this marketing campaign is that while the blood-thinner was sold on the basis of convenience, vitamin K infusion didn’t work to alter its activity. Without an available antidote, internal bleeding from Pradaxa as well as stroke and other serious alleged health consequences were linked to 260 patient deaths as its first year of availability came to a close.

Towards the end of 2011, the FDA released a safety warning to the general public and medical professional community indicating that out-of-control internal bleeding from Pradaxa may present serious risks to takers of the blood thinner.

Priority Review and Final Approval

Dabigatran spent a full five years on the market before the FDA was able work with Boehringer Ingelheim to get a remedy for internal bleeding from Pradaxa under priority review.

This priority review was undertaken in late April of 2015, and Praxbind, the new reversal agent for Pradaxa, was approved in October of that same year. The new antidote came too late for those who suffered purportedly permanent ill effects and even death from internal bleeding from Pradaxa.

This five-year gap has sparked outrage and fueled multiple lawsuits against Boehringer Ingelheim. The allegations in these lawsuits are similar. The pharmaceutical company stands accused of knowing about these potential side effects and not warning or notifying current patients or physicians.

If you have suffered as a result of taking Pradaxa, you may benefit from consulting a knowledgeable pharmaceutical product liability attorney. A Pradaxa lawsuit may help you recover compensation for your losses.