Patients who suffer from atrial fibrillation (Afib) and embolism and may be prescribed blood thinners should be aware of Pradaxa information on efficacy and risks, as this is one of the “novel oral anticoagulants” (NOACs) that have been developed in recent years to replace the old standby, warfarin.

Pradaxa can be highly effective at preventing stroke. However, its mechanism of action has been implicated in a number of serious injuries and even death due to uncontrollable bleeding. What follows is Pradaxa information on how it prevents stroke, treats symptoms of Afib, and how it may lead to dangerous or fatal hemorrhaging.

Pradaxa and Other NOACs: a Brief History

Pradaxa
(dabigatran) is part of a class of drugs that are commonly referred to as “blood thinners,” although this description is not entirely accurate. More precisely, Pradaxa and other NOACs are anticoagulants; they operate by inhibiting the action of various substances in the blood that allow clotting. This is the reason that such medications pose a hazard of serious bleeding.

Dabigatran was first developed from a group of chemicals known since the 1980s to disable the mechanism of thrombin, an enzyme in the blood that promotes blood clotting. Pradaxa was first approved in 2008 by the European Medicines Agency for the treatment of venous thrombosis that can sometimes occur in patients who have joint surgery. Based on Pradaxa information on its effectiveness for preventing stroke in patients suffering from Afib, the medication was granted FDA approval.

Pradaxa Mechanism of Action

Pradaxa is what is known as a “direct thrombin inhibitor.” As noted earlier, thrombin (also known as Factor Iia) is a biochemical substance that causes blood to form clots. This is very useful in cases of external injuries, but can be very dangerous when clots form inside the arteries.

Prior to the introduction of Pradaxa, the first-line treatment for patients at risk for stroke was warfarin, a form of rat poison first developed around 1950. Warfarin inhibits the action of Vitamin K, which is another element important in the formation of blood clotting. For this reason, patients on warfarin faced many dietary restrictions. There are also many interactions with other drugs, and warfarin patients require frequent monitoring.

Pradaxa information indicated to physicians that such a drug would be much easier to administer because there are far fewer interactions and less patient monitoring. However, a patient who started bleeding while on Pradaxa risked hemorrhaging to death, whereas bleeding due to warfarin could be stopped by dosing the patient with Vitamin K.

Further Pradaxa Information

In 2015, an antidote for Pradaxa bleeding received FDA approval. Praxbind (idarucizumab) was developed by German pharmaceutical company Boehringer Ingelheim, which also developed Pradaxa. The “mab” suffix of the drug’s scientific name identifies it as a “monoclonal antibody,” which can be engineered to bind to specific substances. A manufacturer-sponsored study found that Praxbind could reverse bleeding caused by Pradaxa within a few minutes.

Some Pradaxa lawsuits against Boehringer-Ingelheim claim that the manufacturer was aware of the hemorrhaging danger of Pradaxa and failed to disclose this information to the public.

This article is not legal advice or medical advice. It is presented
for informational purposes only.