Pradaxa Linked to Brain Bleeds

Researchers report that they have found a possible link between the anticoagulant drug Pradaxa and intracerebral hemorrhage (brain bleeding).

When a blood vessel wall or vein is damaged, the vessel can leak blood into tissues, causing a hematoma, a swelling of clotted blood within the tissues. The hematoma can be cause swelling and pain.

Anticoagulants, also called blood thinners, can increase the risk for hematomas to expand because the body cannot adequately repair blood vessels. Blood continually seeps into the damaged areas. Hematomas in the brain are especially dangerous because the skull is rigid and cannot expand to accommodate the hematoma like the skin can. A hematoma in the brain increases pressure and impairs brain function.

Pradaxa (dabigatran) received approval from the Food and Drug Administration (FDA) in 2010. Pradaxa is prescribed to reduce the possibility of a stroke in patients with atrial fibrillation, a type of irregular heartbeat. People with atrial fibrillation have a five times greater risk of stroke than the general population, according to Top Class Actions.

A 2011 article in Stroke, a publication of the American Heart Association, reported that mice given Pradaxa developed intracerebral hematoma expansion during the first three hours on the drug.

Boehringer Ingelheim, the manufacturer of Pradaxa, has been accused of failing to warn the public and the medical community of the link between Pradaxa and intracerebral hemorrhage.

Since its release, Pradaxa has been marketed as a safer, more convenient alternative to warfarin, which has been the standard anticoagulant treatment for 60 years. But studies have shown that Pradaxa has an equal or greater risk for bleeding problems than warfarin. And until late 2015, there was no antidote to administer to a Pradaxa patient in the event of a bleeding episode. The antidote Praxbind (idarucizumab) became available in December 2015 for “emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects,” such as when a patient experiences spontaneous bleeding, or has an injury or requires emergency surgery. But Praxbind arrived years too late for Pradaxa users who had already had bleeding episodes and suffered injuries.

Pradaxa was considered more convenient than warfarin because warfarin users need regular blood monitoring and they must follow dietary restrictions. Pradaxa came to market without these restrictions and Boehringer Ingelheim insisted that no monitoring was necessary.

Between October 2010 and March 2011, Pradaxa’s label did not offer information about dosing recommendations and a patient’s weight. Some doctors say a uniform dose is not appropriate for every patient. If the patient’s Pradaxa dose is too low, the patient can still be at risk of blood clots and stroke. If the dose is too high, the patient risks life-threatening internal bleeding.