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  • FDA Date: 04/30/2013

    Samsca (tolvaptan) FDA Drug Safety Communication

    FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    The U.S. Food and Drug Administration (FDA) 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 because it can cause liver injury, potentially requiring liver transplant or death. Samsca is used to treat low sodium levels in the blood. 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). FDA has worked with the manufacturer to revise the Samsca drug label to include these new limitations.

    The Samsca drug label has been updated to include the following information:

    - Limitation of the duration of Samsca treatment to 30 days. (Dosage and Administration and Warnings and Precautions sections)

    - Removal of the indication for use in patients with cirrhosis, a condition that involves scarring of the liver due to injury or long-term disease. Use of Samsca in patients with underlying liver disease, including cirrhosis, should be avoided because the ability to recover from liver injury may be impaired. (Indications and Usage and Use in Specific Populations sections)

    - Description of liver injuries seen in clinical trials of patients with autosomal dominant polycystic kidney disease (ADPKD).

    - Recommendation to discontinue Samsca in patients with symptoms of liver injury.

    The manufacturer of Samsca, Otsuka American Pharmaceutical, Inc., issued a Dear Health Care Provider letter on the potential risk of liver injury on January 22, 2013. FDA is reviewing the information from clinical trials of patients with ADPKD and will update the public on the risk of liver injury with Samsca if more information becomes available.

    View the full FDA Drug Safety Communication on FDA.gov