FDA restricts use of liver disease drug in certain patients
The agency added new warnings to the prescribing information for obeticholic acid, including a contraindication in patients with primary biliary cholangitis and advanced cirrhosis.
The FDA announced on May 26 that it is restricting the use of obeticholic acid (Ocaliva) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis.
The agency added a new contraindication, its strongest warning, to the prescribing information and patient medication guide, stating that the liver disease medication should not be used in patients with PBC and advanced cirrhosis. A boxed warning will also include this information and related warnings about this risk.
In the five years since the drug's accelerated approval, the FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with the drug in patients with PBC and cirrhosis. Many of the patients had advanced cirrhosis before starting the drug. Based on the original clinical trials, the FDA believes the benefits of the drug outweigh the risks in patients with PBC who do not have advanced cirrhosis.