Researchers have found a possible link between anticoagulant Pradaxa and intracerebral hemorrhage (brain bleeding).

Pradaxa has also allegedly been correlated with hematoma expansion.

When a blood vessel wall or vein is damaged, it can leak blood into tissues where it shouldn’t be. The hematoma can be small or it can be large and cause swelling and pain.

Anticoagulants, commonly called blood thinners, can increase the risk for hematomas to expand because the body is unable to efficiently repair blood vessels. Blood then continually seeps into the damaged areas.

Hematomas in the brain are the most dangerous because the skull is enclosed and cannot expand like skin can. When a hematoma develops in the brain, it increases pressure and impairs brain function.

The FDA approved Pradaxa in 2010 as an anticoagulant to reduce the possibility of a stroke in patients with atrial fibrillation, a type of irregular heartbeat that occurs when or both upper heart chambers function erratically.

Irregular blood flow causes clotting to occur more frequently in people who have atrial fibrillation, which leads to them having an increased risk of stroke that is five times that of the general population.

Atrial fibrillation itself is not a life-threatening condition.  Strokes that result from this ailment are more likely to be severe, with a higher incidence of death and disability.

Pradaxa and Intracerebral Hemorrhage

According to a 2011 issue of Stroke online magazine by the American Heart Association, when mice were given Pradaxa (dabigatran-etexilate), rResearchers observed intracerebral hematoma expansion during the first three hours.

A higher dose of Pradaxa increased the hematoma volume substantially within a three-hour period.

Drug manufacturer Boehringer Ingelheim has been accused of failing to warn of the link between Pradaxa and intracerebral hemorrhage.

Pradaxa’s Real Dangers

Pradaxa has been marketed as a safer, more convenient anticoagulant than warfarin.

However, studies show that Pradaxa has an equal or higher risk for bleeding problems than warfarin does. Also, there are antidotes for excessive bleeding caused by warfarin.

An antidote for Pradaxa did not exist until December 2015 when Praxbind became available. Praxbind was several years too late, especially for those who suffered from Pradaxa and intracerebral hemorrhage, say those who suffered from impairment following the drug’s use.

Pradaxa was sold as a more convenient drug than warfarin because the latter needs regular blood tests to determine clot formation capabilities. Boehringer Ingelheim insisted that Pradaxa was “one size fits all” and no monitoring was necessary.

Between October 2010 and March 2011, Pradaxa’s label did not include complete information regarding dosing recommendations and a patient’s weight.

One uniform dose does is not appropriate for everyone, say some doctors who have witnessed Pradaxa side effects firshtand.

If Pradaxa is given at such a low dose that it is not therapeutic, the patient can still be at risk of blood clots and a possible stroke. On the contrary, if a dose is too high, the patient is at risk of seeing life-threatening internal bleeding episodes.

This includes the alleged link found between Pradaxa and intracerebral hemorrhage.

If you or someone you love has been affected by Pradaxa and intracerebral hemorrhage, you could benefit from a class action lawsuit against Boehringer Ingelheim to compensate you for pain and suffering, lost wages, hospitalizations and other medical expenses.