Liver Injury With Oral Anticoagulants Is Rare

There are reports of liver injury associated with Pradax® (dabigatran).

There are over 130 reports of liver injury in people taking dabigatran worldwide…including over 25 in Canada.

In some cases the liver injury is considered severe…ranging from elevated liver enzymes, jaundice, acute hepatic failure, to even death.

Put this in perspective however. There is no proof that Pradaxa or other direct oral anticoagulants (DOACs) cause liver injury.

In most of the Pradaxa cases, other meds or medical conditions may have led to this liver injury.

Health Canada is planning to update Pradaxa labelling…to inform clinicians about these case reports. Health Canada will also continue to monitor for liver injury with other DOACs.

Patients to continue Pradaxa or other DOACs as prescribed. The benefits…such as reducing stroke risk…far outweigh any rare risk of liver injury.

Signs of liver injury…yellowing of eyes or skin, itchy palms or soles without rash, dark urine, pale stool, etc.

If a patient has severe liver injury and still needs anticoagulation, use warfarin or a low-molecular-weight heparin. Lean away from warfarin if baseline INR is elevated.