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FDA Alerts

FDA Limits Duration and Usage of Samsca

The US Food and Drug Administration (FDA) has determined that the drug Samsca (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 requiring liver transplant or death.

Tolvaptan has Liver Injury Risk Says FDA

Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca.

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