FDA Adds Boxed Warning to Rare Liver Disease Drug

Obeticholic acid was incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis, according to the FDA.

Officials with the FDA have added a boxed warning label to liver disease medicine obeticholic acid (Ocaliva, Intercept) to highlight the correct dosing for patients with rare chronic liver disease, according to a FDA safety announcement.

According to the announcement, obeticholic acid has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), increasing risk of liver injury. The addition of the boxed warning will clarify the current recommendations for screening, dosing, monitoring, and managing PBC patients taking the medication.

This information will be highlighted in the prescribing information of the drug label. The FDA is also requiring a medication guide for patients to inform them about this issue.

Health care providers should follow the recommended dosing regimen on the drug label, which is based on calculating a Child-Pugh score in PBC patients with suspected liver cirrhosis before treatment to determine their specific classification and starting dosage. According to the safety announcement, dosing higher than recommended can increase the risk for liver decompensation, liver failure, and sometimes death.

Health care providers should also educate patients and caregivers on the symptoms of worsening liver function and temporarily stop obeticholic acid in those with laboratory or clinical evidence of worsening liver function.

FDA officials are requiring Intercept Pharmaceuticals to continue studying the medication in patients with advanced PBC and they said they will continue to monitor this medicine and update the public if new information becomes available.


FDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease [safety announcement]. FDA’s website. https://www.fda.gov/Drugs/DrugSafety/ucm594941.htm. Accessed February 1, 2018.

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