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

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Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: FDA limits duration and usage of Samsca, active ingredient tolvaptan, due to possible liver injury leading to organ transplant or death

Lesley Navin, a nurse in the Division, will provide you with additional information about this Communication.

Lesley Navin: On April 30, 2013 the FDA determined that the drug 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.  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, also known as 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.
  • 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.
  • Description of liver injuries seen in clinical trials of patients with autosomal dominant polycystic kidney disease, also known as 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.

At this time FDA recommends Healthcare Professionals be aware of the following:

  • Samsca treatment should be stopped if the patient develops signs of liver disease.
  • Limit the duration of Samsca treatment to 30 days or less.
  • Avoid use of Samsca in patients with underlying liver disease, including cirrhosis, because the ability to recover from liver injury may be impaired.
  • Report adverse events involving Samsca to the FDA MedWatch program at: www.fda.gov/MedWatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  A link to previous communications and this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Info for up to the minute important drug information.  Know the moment it happens. 

 

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