Boehringer Ingelheim got the approval to market the anticoagulant drug Pradaxa in the U.S. in 2010 from the U.S. Food and Drug Administration (FDA).

Very quickly after its introduction to the market, Pradaxa adverse events involving uncontrollable bleeding began to be reported.  Some of these Pradaxa adverse events underscored a reality that the pharmaceutical company was not able to address until years after Pradaxa’s release–namely, that the medication had no available antidote.

What is Pradaxa?

Pradaxa is a new blood-thinning medication that is used most often to prevent blood clots in those inclined to produce them through a condition known as Deep Vein Thrombosis, or DVT. People with DVT suffer from blood clots that form in their lower extremities. When the clots break off and travel to the heart and lung region, they can cause respiratory or cardiac arrest. This condition is called Pulmonary Embolism (PE).

Pradaxa is often prescribed to post-surgical patients who have had highly-invasive surgeries such as total knee arthroscopy (TKA) or total hip arthroscopies (THA). These surgeries are more often known as knee or hip replacements and the production of blood clots during the healing process is common.

Pradaxa is a direct thrombin inhibitor, one of several medications that form a class of drugs known as the new oral anticoagulants (NOACS). These drugs were made by various manufacturers to specifically compete in the marketplace with a long-standing blood thinner used for nearly six decades—warfarin.

Warfarin, unlike the newer anticoagulants, requires patients to follow strict protocols in order for the medication to be successful. Because the antidote for uncontrolled bleeding for users on warfarin is a dose of vitamin K, patients taking the drug must avoid green, leafy vegetables that are known to have high vitamin K content such as kale, spinach, brussel sprouts, and chard. They also must have their blood monitored to check for prothrombin time (PT).  PT is the amount of time it takes for a blood clot to form, and this information is used to adjust dosage for prescriptive effectiveness.

Pharmaceutical companies like Boehringer Ingelheim selectively promoted their direct thrombin inhibitor by making claims that no dietary changes or blood monitoring were necessary while taking the medication. This marketing effort was supposed to set it apart from warfarin in the minds of consumers because of its alleged convenience.

After marketing Pradaxa, Pradaxa adverse events started to be reported to the FDA. After its release, 307 incidents of internal bleeding injuries in the gastrointestinal tract and other locations were added to the FDA database. Pradaxa adverse events involving wrongful death were allegedly numbered at about 3000 by the end of its first year on the market.

Internal bleeding events could not be managed by emergency room personnel as they could with warfarin. There was no antidote for the blood-thinning adverse effects. It was not until five years after market release that the reversal agent Praxbind was released. Some consumers believe that the FDA fast-tracked the approval of Praxbind out of sheer necessity. For those who suffered Pradaxa adverse events prior to the release of Praxbind, it was a solution offered a little too late.