Samsca Liver Injury Warning Issued By FDA

Federal drug experts are placing a one month limit on the recommended use of Samsca, a hyponatremia drug that has been linked to a risk of liver damage.  

The FDA issued a drug safety communication (PDF) on April 30, indicating that Samsca should not be used for longer than 30 days. The agency also warned that the drug should not be used in patients with underlying liver disease.

Samsca side effects have been associated with a potential risk of severe liver injury, which could result in the need for a liver transplant or death, according to the warning.

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Along with the announcement, the FDA announced that it is updating the Samsca warning label to included a 30 day limit on use, the contraindication for patients with liver disease, and descriptions of liver problems from Samsca seen during clinical trials. The label will also recommend that doctors discontinue use when a patient shows signs of liver injury.

Samsca (tolvaptan) is an Otsuka Pharmaceutical Co. drug approved for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, a condition that results in critically low salt levels. It belongs to a family of drugs known as selective vasopressin V2-receptor antagonists.

There have been about 16,000 prescriptions for Samsca since it was approved in May 2009.

The FDA began looking at the drug’s safety profile after Otsuka sent out a Dear Healthcare Provider letter (PDF) on January 22, warning that Samsca liver injury could be permanent and fatal. The letter came after three clinical trial patients suffered liver damage while taking the drug. All three recovered after they stopped taking Samsca.

The FDA now believes that Samsca can cause serious and fatal liver injury. The agency warned doctors to look for signs of liver injury among patients taking Samsca. Samsca patients should talk to their doctor if they experience:

  • Loss of appetite
  •  Nausea or vomiting
  •  Fever
  •  Unusual fatigue
  •  Itching
  •  Yellowing of the skin or eyes
  •  Unusually dark urine
  •  Pain in the right upper abdomen


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