Pradaxa is the first of the new generation anticoagulant drugs introduced in 2010.

However, reports of serious and even life-threatening side effects, including Pradaxa cerebral hemorrhaging, have prompted the Food and Drug Administration (FDA) to evaluate potential dangers associated with this drug.

Pradaxa is a direct thrombin inhibitor used to reduce the risk of stroke and embolism in patients with non-valvular atrial fibrillation.

It was approved by the U.S. Food and Drug Administration (FDA) in 2010 and was the first anti-coagulant to be introduced in the United States in more than 50 years.

Pradaxa Cerebral Hemorrhaging

Anticoagulants always carry a bleeding risk, but The Institute for Safe Medicine Practices (ISMP) released a report in January 2012, citing 505 cases of Pradaxa bleeding. The alternative anticoagulant, Warfarin, only had 176 reports.

The Journal of Neurosurgery has also reported that doctors should be alerted to the potential for Pradaxa cerebral hemorrhaging in patients taking the generic form of Pradaxa.

The Journal cited a case report in which an 83-year-old man on Pradaxa died from uncontrollable brain bleeding following a minor fall. Three doctors from the University of Utah cared for the man, who was initially alert and could answer questions.

Despite the doctors’ best efforts, they were unable to reverse the blood-thinning effects of Pradaxa, and the man died of a cerebral hemorrhage.

In September 2013, the Journal of Neurosurgery published a study of ground-level falls in five patients on Pradaxa and 15 on warfarin. Death occurred in 40% of Pradaxa patients who had a cerebral hemorrhage (brain bleeding) after a fall, versus 0% for patients on warfarin.

The authors of the study were concerned about the lack of guidelines and protocols for how to reverse the anti-coagulation effects of Pradaxa, which significantly increased the risk of death.

What is a Cerebral Hemorrhage?

A cerebral hemorrhage occurs when an artery in the brain bursts and causes bleeding in the brain. The pressure from the localized bleeding can kill brain cells and lead to death in some cases.

Symptoms of Pradaxa cerebral hemorrhaging include:

• Sudden headache
• Chest pain and pressure
• Changes in vision
• Tingling or numbness
• Difficulty speaking or swallowing
• Loss of coordination and balance
• Nausea or vomiting
• Loss of consciousness

Pradaxa FDA Warning

Soon after FDA approval, reports began to show that Pradaxa could cause serious and potentially irreversible internal bleeding. Within the first six months after the drug’s release, the FDA received more than 500 reports of internal bleeding and deaths from conditions like Pradaxa cerebral hemorrhaging.

While the FDA approved a Pradaxa antidote in December 2015, this bleeding reversal agent came too late for many patients who suffered serious and sometimes fatal bleeding events.

With the lack of a Pradaxa antidote for more than five years, this meant that if Pradaxa cerebral hemorrhaging occurred, doctors had few options in effectively treating the bleeding.

Lawsuits Filed Over Pradaxa Cerebral Hemorrhaging

Several lawsuits have been filed on behalf of Pradaxa users who suffered serious or fatal brain hemorrhaging.

The majority of these Pradaxa lawsuits have been consolidated into federal multidistrict litigation, In re: Pradaxa Product Liability Litigation, MDL No. 2385, U.S. District Court for the Southern District of Illinois, pending before Judge David R. Herndon.

If you or a loved one suffered a cerebral hemorrhage while taking Pradaxa, you may also be able to seek compensation for your losses. To find out if you can file a claim for a monetary award, contact an experienced Pradaxa attorney today for a no cost, no obligation case review.