Tolvaptan (Samsca)
For more on this Drug Safety Labeling Change, click here.
For full prescribing information, click here.
Updated Boxed Warning
WARNING: NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
Because of the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS.
Public Information from the FDA and Medscape
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Cite this: Drug Safety Warnings and Updates: April-June 2018 - Medscape - Sep 10, 2018.