FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

FDA Adds Black Box Warning to Intercept’s Liver Disease Medicine

Feb. 7, 2018

The FDA issued a black box warning for Ocaliva (obeticholic acid), a liver disease medication that was incorrectly dosed as daily instead of weekly for patients with primary biliary cholangitis, increasing the risk of serious liver injury and worsening liver problems.

The agency advises health care professionals to follow the Ocaliva dosing regimen described on the drug label. “Dosing higher than recommended in the drug label can increase the risk for liver decompensation, liver failure, and sometimes death,” the safety announcement stated.

It also advises providers to stop issuing Ocaliva for patients with evidence of worsening liver function and monitor their liver function. The drug may need to be discontinued for patients who have experienced clinically significant liver-related adverse reactions.

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