Translation of e a-t 4/2022a

Side Effects

OBETICHOLIC ACID: RESTRICTIONS ON USE IN SWITZERLAND TOO

As ordered in the US in 2021 (e a t 6/2021b), restrictions on the use of the farnesoid X receptor agonist obeticholic acid (OCALIVA) have now been imposed in Switzerland too (1). Obeticholic acid is authorised as a reserve option to treat primary biliary cholangitis if ursodeoxycholic acid (URSOCHOL, generics), recommended as the substance of first choice in guidelines (e.g. 2), is not sufficient or is not tolerated (3). Like in the US, obeticholic acid is now contraindicated in Switzerland not only in patients with total occlusion of the bile duct but also in patients with decompensated cirrhosis of the liver (e.g. Child-Pugh B and C), with a history of a decompensation event and in compensated cirrhosis with signs of portal hypertension and must also be permanently discontinued if these conditions develop during treatment. The background to this are reports of liver decompensation and liver failure during treatment with obeticholic acid in patients with cirrhosis, some of which were fatal or required a transplant (1,4). Changes to the Summary of Product Characteristics (SPC) in the EU are also in preparation: according to the minutes of a session from mid-December 2021, however, only a new contraindication for decompensated liver cirrhosis or a previous decompensation event is planned (5). We still consider obeticholic acid to have a disputed treatment principle for which a clinical benefit has not as yet been proven in patients who have risk signals for serious liver damage, -Ed.

©  arznei-telegramm (Berlin/Germany), April 2022, protected by copyright laws.

Autor: Redaktion arznei-telegramm - Wer wir sind und wie wir arbeiten

Diese Publikation ist urheberrechtlich geschützt. Vervielfältigung sowie Einspeicherung und Verarbeitung in elektronischen Systemen ist nur mit Genehmigung des arznei-telegramm^® gestattet.