What is a cerebral hemorrhage? For some Pradaxa users, it’s a life-threatening side effect that’s as bad as the conditions the drug is meant to prevent, and it could be the basis for a Pradaxa lawsuit.

Pradaxa is the brand name for the drug dabigatran, developed and manufactured by Boehringer Ingelheim Pharmaceuticals Inc. It’s one of a new generation of anticoagulant medications that entered the market a few years ago.

Before Pradaxa, warfarin had been the go-to anticoagulant since the 1950s. These new medications were purported to have certain advantages over warfarin, such as fewer interactions with food or other drugs and freedom from ongoing blood monitoring.

These advantages made Pradaxa fairly popular fairly quickly. From its introduction in October 2010 through December 2013, Pradaxa was prescribed over six million times to over 900,000 patients. However, as with all anticoagulants, Pradaxa creates a risk of cerebral hemorrhage and other types of excessive internal bleeding.

Pradaxa cerebral hemorrhage was noted in some of the clinical studies conducted on Pradaxa. One study known as the RE-LY study noted instances of hemorrhagic stroke and bleeds beneath the membranes around the brain.

What Is Cerebral Hemorrhage?

Any bleeding in or around the brain itself can be referred to as a cerebral hemorrhage. This type of bleeding can include a hemorrhagic stroke, which occurs due to a leak or rupture of a blood vessel inside the brain. Ironically, prevention of stroke is one of the FDA-approved uses for Pradaxa – and what is cerebral hemorrhage but a condition similar to one the drug is used to prevent?

Pradaxa cerebral hemorrhage can deprive the brain of oxygen, which itself can result in the death of brain cells. The resulting cerebral hemorrhage symptoms can include:

• Abnormalities like tingling, numbness or paralysis in the face, arm or leg
• Difficulty with speaking or swallowing
• Difficulty with reading or writing
• A sudden and severe headache
• Abnormalities of vision
• Changes in consciousness or alertness

Pradaxa Lawsuits

Cerebral hemorrhage symptoms have been cited in some of the thousands of Pradaxa lawsuits filed in the roughly five years the drug has been on the market. These and other claims have already yielded millions of dollars in settlement funds for plaintiffs. In 2014, Boehringer Ingelheim agreed to settle about 4,000 Pradaxa lawsuits to the tune of $650 million.

Some claimants argued that Pradaxa treatment should be accompanied by regular blood testing, contrary to the company’s promotional materials.

Internal documents made public in the course of litigation revealed that Boehringer employees did indeed call for suppression of further research on Pradaxa, out of fear that further research would give patients the impression that they should be undergoing blood testing while taking Pradaxa.

Freedom from such regular blood testing, as is required with warfarin, had been a major selling point for Pradaxa.

The plaintiffs generally alleged that Pradaxa had caused cerebral hemorrhage symptoms and other types of excessive bleeding that were life-threatening and in some cases fatal. They argued Boehringer Ingelheim was at fault for failing to properly warn patients and doctors about the risks of Pradaxa bleeding.