FDA limits duration and usage of Tolvaptan (Samsca) due to possible liver injury leading to organ transplant or death
Last Updated on May 2, 2013 by Joseph Gut – thasso
April 30, 2013 – The U.S. Food and Drug Administration (FDA) has determined that the drug Tolvaptan (Samsca) 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. Tolvaptan (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 Tolvaptan (Samsca) for a new use in patients with autosomal dominant polycystic kidney disease (ADPKD. FDA has worked with the manufacturer to revise the Tolvaptan (Samsca) drug label to include these new limitations.
The Tolvaptan (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 Tolvaptan (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 Tolvaptan (Samsca) if more information becomes available.