The FDA has determined that Samsca (tolvaptan; Otsuka) tablets should not be used for longer than 30 days and should not be used in patients with underlying liver disease due to possible livery injury (including cirrhosis), which can lead to liver transplant or death. An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca for a new use in patients with autosomal dominant polycystic kidney disease (ADPKD).
The FDA is working with the manufacturer to revise the drug label to include the new limitations. In January 2013, Otsuka and the FDA initially notified healthcare professionals of significant hepatic injury associated with the use of Samsca, and recommended that treatment should be discontinued if hepatic injury was suspected.
Samsca is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormone (SIADH).
For more information visit the FDA website.