The FDA ordered doctors to restrict the use of Otsuka Pharmaceuticals' Samsca, or tolvaptan, to 30 days or less because of potential liver damage that could result in organ transplantation or death. The treatment is indicated for clinically significant euvolemic and hypervolemic hyponatremia tied to conditions including heart failure. The agency also discourages the drug's use in patients with underlying liver disease.
FDA restricts use of heart failure drug to 30 days
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