FDA Warns That Tolvaptan Can Lead To Serious Liver Injury

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 More…
Source: CardioBrief - Category: Cardiology Authors: Tags: Heart Failure People, Places & Events Policy & Ethics food and drug administration liver Source Type: blogs