FDA Issues Drug Safety Communication Limiting Duration and Usage of Samsca (Tolvaptan)

The FDA issued a drug safety communication limiting the duration and usage of Samsca (tolvaptan) due to possible liver injury that may result in organ transplant or death. Due to recent clinical trial findings, the Agency warns that patients should not take the drug for longer than 30 days and it should not be used to treat patients with underlying liver disease. Samsca, a selective vasopression V2-receptor antagonist, is used to treat patients with clinically significant hypervolemic and euvolemic hyponatremia, including those with heart failure.

Keywords: Benzazepines, Heart Failure, Receptors, Vasopressin, Hyponatremia, Liver Diseases

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