Boxed warning added to liver disease drug

The drug has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, which increases the risk of serious liver injury, the FDA said.


The FDA announced on Feb. 1 that it will add a new boxed warning to highlight the correct dosing for obeticholic acid (Ocaliva). The drug has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, which increases the risk of serious liver injury, according to the agency. The new warning will highlight current screening, dosing, and monitoring recommendations in the prescribing information of the drug label. In addition, a new medication guide required by the FDA will inform patients about the issue.