FDA restricts use of Intercept drug due to liver injury risk
Dive Brief: The Food and Drug Administration on Wednesday restricted the use of Intercept Pharmaceuticals' liver disease drug Ocaliva after an investigation linked it to severe injuries including liver failure in certain patients. In most cases, the benefits of Ocaliva outweigh the risks for patients with primary biliary cholangitis, the FDA said. But the agency announced Wednesday that doctors should not prescribe the medicine for patients with advanced cirrhosis, or permanent scarring. The new contraindication follows a safety warning added in 2018 to caution physicians about overdosing pat...