Other safety alerts
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| The United Kingdom: Obeticholic acid (Ocaliva▼): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that it is aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Healthcare professionals should follow dose reduction and monitoring advice in these patients to reduce the risk of serious liver injury.
An EU review assessed reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Liver-related adverse events have occurred both early in treatment and after months of treatment. Most cases were in the USA, but cases have also been reported in Europe. The review concluded that no changes to the product information were required but suggested that healthcare professionals should be reminded of the dosing recommendations. A letter has also been sent to prescribers.
MHRA has received 2 Yellow Card reports of hepatobiliary disorders in the UK associated with obeticholic acid. Neither case was fatal, but one case was life-threatening and required hospital admission and the other case led to discontinuation of therapy.
Hepatic status should be determined before starting treatment with obeticholic acid. Hepatically-impaired patients should receive a reduced starting dose of 5 mg once weekly in line with the recommendations in the Summary of Product Characteristics for Ocaliva▼.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/obeticholic-acid-ocaliva-risk-of-serious-liver-injury-in-patients-with-pre-existing-moderate-or-severe-hepatic-impairment-reminder-to-adjust-dosing-according-to-liver-function-monitoring
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the US Food and Drug Administration, and was posted on the Drug Office website on 22 Sep 2017 and 2 Feb 2018.
Ends/Wednesday, Apr 25, 2018
Issued at HKT 16:00
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