Obeticholic acid (Ocaliva) has recently been licenced in Canada for the treatment of people with PBC who have not fully responded to, or who are unable to tolerate, Ursodeoxycholic acid. You may have seen a recent news report from the U.S. regarding some serious adverse outcomes for PBC patients whose prescribed dose of Ocaliva was significantly higher than that recommended and approved by the FDA. This appears to be an issue primarily among patients who have advanced cirrhosis, some of whom have experienced liver injury, liver failure, and even death. We feel it’s important to make sure you are aware of this issue. If you are being treated with Ocaliva and have any questions or concerns about the appropriate dosage level for your stage of PBC, you should talk to your doctor.