Many people need to take blood thinners to help in the prevention of stroke or pulmonary embolism. However, with Pradaxa, a newer anticoagulant, many reports of Pradaxa adverse side effects have concerned patients and the doctors who treat them.

Pradaxa joins Xarelto and Eliquis as a New Oral Anticoagulant (NOAC) medications. Generically known as dabigatran, Pradaxa is manufactured by Boehringer Ingelheim.

Pradaxa was approved by the U.S. Food and Drug Administration in 2010 for the treatment of pulmonary embolism and deep vein thrombosis. Also, some patients who take Pradaxa suffer from atrial fibrillation. Atrial fibrillation is a condition in which blood pools in a chamber of the heart and then raises the risk of clotting.

Pradaxa, along with Xarelto and Eliquis, was brought to market to compete with the standard anticoagulant medication, warfarin. Warfarin has been prescribed for decades for those patients who need blood thinning medication.

The drug makers marketed Pradaxa and other NOACs as superior to warfarin because Pradaxa did not need as much constant blood monitoring as warfarin does. Additionally, a patient on Pradaxa need not change his or her diet as warfarin patients must.

Pradaxa is in the class of anticoagulants called direct thrombin inhibitors. Direct thrombin inhibitors like Pradaxa attach themselves to the thrombin in the blood. Thrombin is a blood component that helps in blood clotting.

Pradaxa and other direct thrombin inhibitors make it so that the thrombin cannot clot as easily.

As successful as Pradaxa and other newer generation anticoagulants have been, there have still been thousands of reports of Pradaxa adverse side effects. As with any blood thinning medication, Pradaxa’s anticoagulant effect can inhibit the blood’s ability to clot when clotting is really necessary, such as during a bleeding injury or emergency surgery.

To help in an emergency, reversal agents are necessary. Warfarin has a reversal agent to help the blood of patients clot when needed. Vitamin K can be administered to warfarin patients to aid in the clotting of blood during an emergency.

However, Pradaxa, for many years, did not have a reversal agent. Only recently has a reversal agent for Pradaxa been available. Praxbind, Pradaxa’s reversal agent, was released in October 2015.

For more than five years that Pradaxa was approved for sale, Pradaxa did not have any reversal agent. Plaintiffs who have filed lawsuits allege this constitutes reckless behavior and that the drug makers had little regard for the safety and health of its patients.

The most serious of the Pradaxa adverse side effects is uncontrollable bleeding. In fact, when Pradaxa was released onto the market, the FDA began receiving Pradaxa adverse side effect reports in the just the first few months. The complaints were of internal hemorrhaging and gastrointestinal bleeding.

In those first three months, the FDA received over 300 Pradaxa adverse side effects reports. Additionally, in the first year, over 260 deaths were reported as a result of Pradaxa use.

If you or someone you love has suffered from Pradaxa adverse side effects, you may benefit from speaking to an attorney experienced in products liability lawsuits.