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FDA issues new communication about risk of liver injury with Ocaliva (obeticholic acid).
The FDA has issued a Drug Safety Communication about an increased risk of serious liver injury with incorrect dosages of Ocaliva (obeticholic acid). The drug is used to treat primary biliary cholangitis (PBC).
Obeticholic acid is being incorrectly dosed in some patients, which results in an increased risk of liver injury and death. The patients being misdosed are those with moderate to severe decreases in liver function who are receiving excessive doses of obeticholic acid, but the drug may be associated with liver injury in some patients with mild disease who are receiving the correct dose.
Health-care professionals, including pharmacists, are recommended to: