As with all other anticoagulants, Pradaxa presents an increased likelihood of internal bleeding. Here’s some basic information about internal bleeding, its causes, and what can be done about it.

Internal bleeding can cause significant inflammation and pain. It can happen in many different areas of the body. More severe cases may put the patient at risk for going into shock.

Understandably, internal bleeding is not as easily identified as bleeding on the outside of the body. Bleeding may continue for several hours before symptoms appear, if at all. The patient may only notice symptoms if the bleeding is particularly heavy.

What Causes Internal Bleeding?

Most commonly, bleeding is caused by an injury. Blunt trauma can cause internal bleeding while leaving the outside of the body not visibly harmed. Broken bones can also cause internal bleeding due to the large number of blood vessels inside and near the bone.

Surgical patients are also vulnerable to internal bleeding that may begin hours or days after surgery is completed. Alcohol abuse and certain anti-inflammatory drugs like aspirin or ibuprofen can also cause internal bleeding.

It’s also possible for internal bleeding to begin spontaneously. Blood thinner side effects include an increased susceptibility to internal bleeding. In patients who take these anti-coagulant drugs like Pradaxa, even a minor injury or illness can cause significant bleeding. This bleeding is the leading cause of injuries and deaths associated with Pradaxa.

Until recently, heavy internal bleeding was an especially dangerous risk for Pradaxa patients because there was no antidote available that could control Pradaxa bleeding once it started.

Patients taking the older anticoagulant warfarin could rely on being able to receive intravenous vitamin K to reverse the drug’s anticoagulant effect in case of excessive bleeding, but Pradaxa patients under the same circumstances could only discontinue Pradaxa and wait for the body to finish metabolizing the drug. It wasn’t until October 2015 that the FDA finally approved a drug that would reverse Pradaxa’s anticoagulant effect.

Pradaxa Litigation

Pradaxa internal bleeding has been the subject of a large number of legal claims against the drug’s manufacturer, Boehringer Ingelheim. Generally, the plaintiffs in these claims allege that Pradaxa puts patients at an unreasonably dangerous risk of internal bleeding serious enough to threaten the patient’s life.

One early blood thinner lawsuit alleges Pradaxa was the cause of a fatal gastrointestinal bleed in a woman who had taken the drug for only three months.

Another blood thinner lawsuit says Pradaxa prevented doctors from saving the life of a woman who hit her head in a fall. The plaintiffs, the woman’s daughters, say her injury caused internal bleeding that her doctors were unable to stop due to blood thinner side effects. They allege their mother’s life could have been saved had she not been on Pradaxa at the time of her injury.

All federal Pradaxa lawsuits have been combined into a multidistrict litigation, or MDL, in a federal court in Illinois. In May 2014, Boehringer Ingelheim agreed to pay $650 million to settle each blood thinner lawsuit pending in the MDL.