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Samsca® (tolvaptan) – Safety update

April 23, 2018 - The FDA approved an update to the Boxed Warning and Contraindications sections of the Samsca (tolvaptan) drug label regarding use in patients with autosomal dominant polycystic kidney disease (ADPKD) outside of the FDA approved Risk Evaluation and Mitigation Strategy (REMS) and the risk of hepatotoxicity.

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