Users of Pradaxa, also known as dabigatran, have reported experiencing serious health problems including life-threatening brain bleeding.

Pradaxa is a new once a day blood thinner from a new class of anticoagulants. It was released to the in October 2010 and was approved to prevent blood clots in patients with atrial fibrillation not caused by heart valve disease and at least one other risk factor for stroke as well as for recent hip or knee replacement operations.

What is Pradaxa?

Pradaxa was developed by Boehringer Ingelheim to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. Anticoagulants reduce blood clotting, which is why they are more commonly called blood thinners.

Anticoagulants like Pradaxa are most commonly used in patients with atrial fibrillation, or an irregular heartbeat. This is because atrial fibrillation increases the risk of stroke, which is many times higher in patients with an irregular heartbeat.

With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing the risk of a stroke.

Pradaxa is designed to lower the chance of blood clots forming and is prescribed to replace other anticoagulants such as warfarin (Coumadin). Wafarin has been predominantly used in the United States to treat blood clots.

Pradaxa Side Effects

There are also a number of side effects from taking Pradaxa. These commonly reported minor Pradaxa side effects include stomach pain, nausea, indigestion, and heartburn.

However, the blood thinning medication has also been linked to more serious and life-threatening complications such as:

• Uncontrolled bleeding
• Chest pain
• Loss of consciousness
• Heart attack
• Liver failure
• Cerebral hemorrhage or brain bleeding

Between its FDA approval and March 2011, the agency received 932 reports of serious Pradaxa adverse events, including 120 deaths and 500 reports of severe, life-threatening bleeding.

As of December 31, 2011, the FDA received more than 500 reports of deaths in the U.S. linked to Pradaxa.

Health regulators in Australia, Japan and Europe have also issued Pradaxa side effects advisories. On September 24, 2012, researchers at the University of Pécs in Hungary warned that patients taking Pradaxa were three times as likely to have an adverse reaction of excessive bleeding.

Pradaxa Brain Bleeding

In March 2012, the Journal of Neurosurgery published 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 5 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.

Pradaxa Lawsuits

By 2012 reports of fatalities, uncontrollable bleeding and hemorrhaging were reported with over 500 deaths attributed to Pradaxa.  Over 4,000 lawsuits against the company were settled in 2014 and the manufacturer agreed to settle multi-district litigation lawsuits for $650 million.

Since then, however, a new round of lawsuits has arisen for those claims not included in the initial settlement. It is widely expected that the claims will again be consolidated into multi-district litigation.

If you are considering Pradaxa, or it has been prescribed to you, be aware of the possible severe complications that can arise. Should you experience a severe adverse effect such as brain bleeding, or other traumatic Pradaxa side effects, speak to your doctor immediately and contact an attorney as soon as possible.