FDA Warns That Tolvaptan Can Lead To Serious Liver Injury 1

The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia. The FDA said tolvaptan “should not be used for longer 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 or death. ”

The liver injury risk was discovered in clinical trials testing tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD). The drug label has been updated and now states that use of the drug should be limited to 30 days and that it is no longer indicated in patients with cirrhosis. The FDA recommended that tolvaptan should be discontinued in patients with liver disease who are currently taking the drug.

 

 

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One comment

  1. Pingback: FDA Advisory Committee recommends against approval of Tolvaptan for polycystic kidney disease | Kidney Disease Drug Development

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