This Ocaliva Label Change Follows September 2017 Dear Doctor Letter Sent By Intercept Pharmaceuticals
An earlier blog post, "Will Ocaliva Get Black-Box Warning For Liver Injury Side Effects After September 2017 FDA Report?", received its answer last week.
On February 1, 2018 the FDA issued this Safety Alert, "Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing", 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.
As a condition of approval, FDA required the manufacturer of Ocaliva, Intercept Pharmaceuticals, to continue studying the medicine in patients with advanced PBC. These clinical trials are currently ongoing and FDA expects to receive results in 2023. 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 will continue to monitor this medicine and will update the public if new information becomes available.
BACKGROUND: This is an update to the MedWatch safety alert for Ocaliva (obeticholic acid) - Increased Risk of Serious Liver Injury, issued 09-21-2017.
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From the Full Prescribing Information for Ocaliva (accessed 2/1/18), here is the so-called "Black-Box Warning" text being added:
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS
• In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with primary biliary cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended [see Warnings and Precautions (5.1)].
• The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event [see Dosage and Administration (2.2)].
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:
Ocaliva (obeticholic acid) is Intercept's sole marketed product, winning approval in May 2016 for a rare type of chronic liver disease known as primary biliary cholangitis or PBC. Few other treatments exist for the progressive disease, which can lead to cirrhosis and liver failure....
In September, the company 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. [Note: Added link to this Intercept Pharmaceuticals letter about Ocaliva dated 9/8/17.]
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.
Lastly, according to Intercept Pharmaceutical’s February 1, 2018 press release, the company is also working with the European Medicines Agency to update the Ocaliva drug label in Europe and will issue a Direct Healthcare Professional Communication to educate physicians on the appropriate Ocaliva dosage for patients with advanced cirrhosis.
We are investigating drug-induced liver injury and hepatic / liver failure cases as possible drug injury lawsuits against Intercept Pharmaceuticals.
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