While many Pradaxa lawsuits have already been settled, many are still concerned with the Pradaxa bleeding risks and the lack of antidote. The easy-to-use blood thinner has proved to be far less “easy” than originally supposed.

About Pradaxa

Pradaxa is an anticoagulant that was approved in 2010. It was marketed as an alternative to warfarin, the go-to blood thinner that has been used for years. Boehringer Ingelheim Pharmaceuticals told users that they would not have to come in for regular blood testing while using Pradaxa and that users would not have to adhere to a strict diet. Because of this apparent ease, countless individuals used the drug believing it to be safe.

However, consumers immediately began suffering from Pradaxa complications such as internal bleeding. Pradaxa bleeding was allegedly not adequately warned against by the drug manufacturer. The Pradaxa bleeding risk is increased due to the fact that there is currently no Pradaxa antidote.

If a warfarin patient suffered from internal bleeding, there is a Vitamin K antidote than can be used to stop the bleeding. There is no way to stop Pradaxa complications. Boehringer Ingelheim Pharmaceuticals is currently working on an antidote, which the FDA is currently reviewing.

Pradaxa Bleeding Risks

Pradaxa was put on the “fast track” for approval. This means that only one clinical trial was used for the basis of approval. The lack of proper trials prevented consumers from being aware of Pradaxa complications.

4,000 Pradaxa lawsuits were filed against the drug manufacturer claiming that the anticoagulant was responsible for the serious injury or death of the Pradaxa patients. 

Despite the high dangers, Pradaxa is still being used by hundreds of thousands of individuals. There is a question as to whether or not this is safe due to the Pradaxa bleeding risk.

One solution presented was to start doing blood tests on patients to monitor the drug’s effect on the body. According to a study performed by Boehringer Ingelheim Pharmaceuticals, blood monitoring would decrease Pradaxa bleeding cases. It was claimed that Pradaxa bleeding cases would decrease by 30 percent to 40 percent if blood monitoring was used.

This would, however, mean that the “easy-to-use” drug was not much different than warfarin. But even at this time, patients are not able have a blood test for Pradaxa because the test has not been FDA approved.

Perhaps the Pradaxa antidote, if approved, will change the serious dangers caused by the anticoagulant. Until then, the drug manufacturer will likely continue to face thousands of Pradaxa lawsuits. Already $650 million has been paid in settlements.