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FDA is adding a Boxed Warning, its most prominent warning, on a liver disease medicine.
FDA is adding a Boxed Warning, its most prominent warning, on the liver disease medicine obeticholic acid (Ocaliva, Intercept Pharmaceuticals).
Ocaliva has been incorrectly dosed daily, instead of weekly, in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury, FDA said in a MedWatch Safety Alert.
“FDA is adding the additional warnings to the drug label after receiving reports that Ocaliva is being given to PBC patients with moderate to severe liver impairment more often than is recommended in the prescribing information, resulting in liver decompensation, liver failure, and sometimes death,” FDA said in the Alert.
The new Alert updates FDA’s MedWatch safety alert for Ocaliva, issued last September, for increased risk of serious livery injury.
As a condition of approval, FDA required Intercept to continue studying the medicine in patients with advanced PBC. The clinical trials are currently ongoing and FDA expects to receive results in 2023.
Meanwhile, healthcare professionals should know that dosing higher than recommended in the drug label can increase the risk for liver decompensation, liver failure, and sometimes death. “Routinely monitor all patients for biochemical response, tolerability, and PBC progression, and re-evaluate Child-Pugh classification to determine if dosage adjustment is needed,” FDA said in the Alert.
“Close monitoring is recommended for patients at an increased risk of liver decompensation, including those with laboratory evidence of worsening liver function (e.g., total bilirubin, INR, albumin) or progression to cirrhosis,” the agency added.
Healthcare professionals should temporarily stop Ocaliva in those with laboratory or clinical evidence of worsening liver function that may indicate decompensation and monitor the patient’s liver function. “Consider discontinuing Ocaliva in patients who have experienced clinically significant liver-related adverse reactions,” FDA said.