On September 21, 2017, the FDA issued a drug safety communication for the medication, Ocaliva. The communication highlighted the increased risk of serious liver injury due to being incorrectly dosed in some patients with moderate to severe decreases in liver function.
Ocaliva Latest News
Get the latest updates on this drug from the GoodRx medical team
On September 21st, the FDA issued a drug safety communication for Ocaliva (obeticholic acid), a medication used to treat primary biliary cholangitis (PBC).
The FDA warns that using Ocaliva can cause serious liver injury and even death when improperly dosed. The FDA has reviewed the 19 cases of death potentially caused by Ocaliva, and determined that in several cases patients with moderate to severe liver disease were receiving too high of a dose. See More