Drug Safety Warnings and Updates: April-June 2018

Beth F. Fritsch, PharmD, MBA, BCPS; Steve Morin, RN

Disclosures

September 10, 2018

Editorial Collaboration

Medscape &

In This Article

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.

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