Drug Safety and Availability > FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death

Drug Safety and Availability > FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death

 

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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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) (See Data Summary).  FDA has worked with the manufacturer to revise the Samsca drug label to include these new limitations.

For more information, please visit: Samsca.

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

View and print full Drug Safety Communication (PDF, 120KB)

• Safety Announcement
• Facts about Samsca (tolvaptan)
• Additional Information for Patients
• Additional Information for Health Care Professionals
• Data Summary
• References

Safety Announcement
[04-30-2013]  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)¹ (See Data Summary).  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.