From the Guidelines
Actigall (ursodeoxycholic acid) is generally not recommended for use in acute hepatotoxicity. The primary treatment for acute hepatotoxicity is to immediately discontinue the offending agent and provide supportive care. Actigall is typically used for chronic liver conditions like primary biliary cholangitis, not acute liver injury. In acute hepatotoxicity, the focus should be on:
- Stopping the hepatotoxic agent
- Monitoring liver function tests closely
- Providing supportive care (IV fluids, electrolyte management)
- Considering N-acetylcysteine in cases of acetaminophen toxicity, as supported by studies such as 1 and 1
- Treating complications like encephalopathy or coagulopathy if they occur Actigall works by altering bile acid composition and reducing cholestasis, which is not the primary issue in most cases of acute hepatotoxicity. Its effects are generally seen over weeks to months, making it unsuitable for acute management. Additionally, introducing a new medication during acute liver injury could potentially complicate the clinical picture. The most recent and highest quality study, 1, provides guidance on the management of acetaminophen overdose, which is a common cause of acute hepatotoxicity, and does not recommend the use of Actigall in this setting.
From the FDA Drug Label
Ursodiol therapy has not been associated with liver damage. Lithocholic acid, a naturally occurring bile acid, is known to be a liver-toxic metabolite. This bile acid is formed in the gut from ursodiol less efficiently and in smaller amounts than that seen from chenodiol Abnormalities in liver enzymes have not been associated with ursodiol therapy and, in fact, ursodiol has been shown to decrease liver enzyme levels in liver disease.
The FDA drug label does not provide information on the use of Actigall (ursodiol) in acute hepatotoxicity. While ursodiol has been shown to decrease liver enzyme levels in liver disease, there is no direct information on its use in acute hepatotoxicity. Therefore, no conclusion can be drawn about its safety or efficacy in this context 2, 2.
From the Research
Acute Hepatotoxicity and Actigall (Ursodiol)
- There is limited evidence on the use of Actigall (ursodiol) in acute hepatotoxicity, with most studies focusing on its preventive effects in specific contexts, such as hepatotoxicity induced by certain medications or procedures 3, 4.
- One study evaluated the efficacy of ursodiol for prevention of hepatotoxicity in patients receiving gemtuzumab ozogamicin and inotuzumab ozogamicin, and found that ursodiol prophylaxis was associated with a similar incidence of hepatotoxicity compared to no ursodiol, but may delay the time to occurrence 3.
- Another study suggested that ursodiol may play a role in preventing hepatic venoocclusive disease (VOD) in patients undergoing allogeneic bone marrow transplantation, although larger, randomized clinical trials are needed to confirm this finding 4.
- There is no direct evidence on the use of Actigall (ursodiol) in the treatment of acute hepatotoxicity, and most studies on hepatotoxicity focus on prevention or management with other agents, such as acetylcysteine 5, 6, 7.
Hepatotoxicity Management
- The management of hepatotoxicity often involves prompt treatment with agents such as acetylcysteine, especially in cases of paracetamol (acetaminophen) overdose 6, 7.
- Monitoring of liver function parameters is crucial in patients at risk of hepatotoxicity, and rising liver function parameters should prompt immediate action to prevent the occurrence of liver failure 5.
- The timing and speed of aminotransferase rises are important in predicting hepatotoxicity, and abnormal and rapidly doubling aminotransferase levels at presentation may indicate severe poisoning 7.