New limitations on tolvaptan due to liver injury risk

The labeling for tolvaptan (Samsca) has been revised due to observation of increased risk of liver injury in recent trials, the FDA announced last week.

According to the new label, tolvaptan should not be used for longer than 30 days and should not be used in patients with underlying liver disease, including cirrhosis, because it can cause liver injury, potentially requiring liver transplant or death. It's also recommended that clinicians discontinue the drug in patients with symptoms of liver injury. These changes are due to liver injuries found in large clinical trials evaluating tolvaptan for use in patients with autosomal-dominant polycystic kidney disease, according to an FDA press release.