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Home / Uncategorized / FDA Samsca Warning: Potential Risk of Liver Injury

FDA Samsca Warning: Potential Risk of Liver Injury

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The U.S. Food and Drug Administration released a Safety Announcement stating that the drug Samsca should not be used for longer than 30 days.  The announcement also said that the drug should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death.

Samsca is a prescription drug used to treat low sodium levels in the blood.  The FDA has worked with the manufacturer to revise the Samsca drug label to include these new limitations.

The updated information on the Samsca drug label includes:

  • Limitation of the duration of Samsca treatment to 30 days. (Dosage and Administration andWarnings 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.

Symptoms of liver problems include:

  • Loss of appetite, nausea, vomiting
  • Fever, feeling unwell, unusual tiredness
  • Itching
  • Yellowing of the skin or the whites of the eyes (jaundice)
  • Unusual darkening of the urine
  • Pain or discomfort in the right upper abdomen, where the liver is located

View the full FDA Drug Safety Communication

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