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FDA Drug Safety Podcast: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On September 21, 2017, FDA warned that the liver disease medicine Ocaliva (active ingredient obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label. We are working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.

Ocaliva is used to treat primary biliary cholangitis (or PBC). PBC inflames and damages the bile ducts in the liver and causes bile to build up. This build-up damages the liver eventually causing liver failure. Ocaliva has been shown to improve a certain blood test that measures liver problems.

Health care professionals should determine baseline liver function prior to starting Ocaliva. Patients with moderate to severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly. Monitor patients frequently for disease progression, and reduce the dosing frequency to once- or twice-weekly for patients who progress to moderate or severe liver impairment. In all patients treated with Ocaliva, monitor frequently and discontinue Ocaliva if liver injury is suspected. After the patient has stabilized, weigh benefits versus risks when deciding whether to re-initiate treatment. Educate patients on the symptoms of potential liver injury.

Since Ocaliva approval in May 2016, FDA received reports of 11 cases of serious liver injury and 19 cases of death associated with Ocaliva. The FDA's Adverse Event Reporting System (FAERS) includes only reports submitted to FDA, so there may be additional cases about which we are unaware.

Side effects involving Ocaliva and other medicines should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication including details of the FAERS reports can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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