The U.S. Food and Drug Administration has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease. That’s because it can cause liver injury, potentially leading to liver transplant or death. The FDA has worked with the manufacturer to revise the Samsca drug label to include new limitations.
Samsca is a selective vasopression V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). 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 has recommended that Samsca treatment should be stopped if a patient develops signs of liver disease. The agency says treatment duration should be limited to 30 days or less, and use should be avoided in patients with underlying liver disease, including cirrhosis. Patients should be made aware that Samsca may cause liver problems, including life-threatening liver failure. They should contact their health care professional to discuss any questions or concerns about Samsca.
Source: FDA MedWatch
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