FDA Issued Drug Safety Communication - Samsca

The U.S. Food and Drug Administration has issued a drug safety communication to alert healthcare professionals that the drug Samsca (tolvaptan) should not be used for more than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant and death. The FDA has worked with the manufacturer to revise the Samsca drug label to include new limitations.
Samsca is a selective vasopression V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). 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.
The FDA is advising that Samsca be discontinued in patients who develop signs of liver toxicity, which may include:
  • Loss of appetite, nausea, vomiting
  • Fever, feeling unwell, unusual tiredness
  • Itching
  • Yellowing of the skin or the whites of the eyes
  • Unusually dark urine
  • Pain or discomfort in the right upper abdomen

Visit: ww.fda.gov/downloads/Drugs/DrugSafety/UCM350084.pdf for the complete FDA Drug Safety Communication.

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