On February 1, 2018 the FDA issued this Safety Alert, “Ocaliva (obeticholic acid): Drug Safety Communication – Boxed Warning Added To Highlight Correct Dosing”, about an Ocaliva label change, from which we get this information:
ISSUE: FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) 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. To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. FDA is also requiring a Medication Guide for patients to inform them about this issue.
From a February 1, 2018 BioPharmaDIVE news report, “FDA adds black box warning to Intercept’s Ocaliva”, we get additional details about this Ocaliva drug safety development:
In September 2017, Intercept Pharmaceuticals issued a so-called “Dear Health Care Provider” letter warning of complications including liver failure and death when patients with moderate to severe PBC received higher-than-intended doses of Ocaliva.
The FDA followed that up with a drug safety communication outlining similar concerns. By the regulator’s tally, nineteen patients receiving Ocaliva died over the 13 months from the drug’s launch through last September. Seven out of the eight fatal cases with available information on cause of death showed the patients had incorrectly received daily doses, instead of the weekly administration recommended for those with moderate to severe declines in liver function.
We are investigating drug-induced liver injury and hepatic / liver failure cases as possible drug injury lawsuits against Intercept Pharmaceuticals.[Read article in full at original source]