When Pradaxa, generically known as dabigatran, was first approved by the U.S. Food and Drug Administration in 2010, it was seen as a blood thinning medication that was far superior to what was currently on the market, namely warfarin.

Pradaxa is now a blood thinning medication that is widely used by patients across America. However, the risk of Pradaxa’s anticoagulant therapy side effects may outweigh the benefits of the drug.

Pradaxa is a direct thrombin inhibitor. It works by inhibiting the enzyme thrombin, which aids in the clotting of blood. It is prescribed for people who are risk for pulmonary embolism (PE) or deep vein thrombosis (DVT).

Before Pradaxa and other similar drugs became available, warfarin (brand name Coumadin) was the anticoagulant that was most often prescribed to those patients at risk for stroke and blood clots. Warfarin, however, requires blood monitoring and dosage monitoring.

Pradaxa has been marketed as a “one dose fits all” type of medication by manufacturing company, Boehringer Ingelheim Pharmaceuticals. Unlike warfarin, Pradaxa does not require regular blood testing.

For some patients, Pradaxa is a drug that does help control blood clotting and prevent strokes and other clot-related conditions. However, it has been noted that the Pradaxa single dose may lead to uncontrollable bleeding in some people; in other patients, the drug may not be strong enough to reduce the risk of stroke or embolism.

Pradaxa’s Anticoagulant Therapy Side Effects

Until just recently, Pradaxa did not have a reversal agent. If a patient who takes Pradaxa experiences uncontrollable bleeding for some reason, that patient may suffer serious consequences, including death.

Some patients are more at risk for negative anticoagulant therapy side effects than others. Those who undergo dental or medical procedures and are on Pradaxa are more at risk for bleeding incidents than others. Also, if Pradaxa patients take other drugs that contain aspirin, it may increase the risk of uncontrollable bleeding.

In 2015, a Pradaxa reversal agent was approved by the FDA. Praxbind, as the drug is called, has been approved to treat Pradaxa patients who experience negative anticoagulant therapy side effects, including uncontrollable bleeding.

Warfarin patients who experience negative anticoagulant therapy side effects need only be administered vitamin K in order to reverse uncontrollable bleeding. But when Pradaxa was released and was promoted as superior to warfarin, some patients say they were left unaware that there was not an adequate reversal agent available.

Many patients who took Pradaxa from 2010 until 2015, when Praxbind was approved, experienced devastating anticoagulant therapy side effects. Many have filed lawsuits against Boehringer Ingelheim, the drug’s manufacturer, claiming failure to warn, design defect and other things.

In 2014, Boehringer Ingelheim paid $650 million to resolve around 4,000 Pradaxa lawsuits in both state and federal courts.

If you suspect you might be experiencing negative Pradaxa anticoagulant therapy side effects, you might experience bruising without any known cause, frequent nose bleeds, bleeding from the gums, discolored urine, red or black stool, coughing up and possibly vomiting blood, joint pain or weakness.

If this occurs, it is recommended you seek out medical attention as soon as possible. Pradaxa patients who experience anticoagulant therapy side effects such as uncontrollable bleeding may also be able to seek legal compensation.