Label Changes for:
Samsca (tolvaptan) 15 mg, and 30 mg Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
'liver disease' term deleted from following text:
- SAMSCA is a prescription medicine used to help increase low sodium levels in the blood, in adults with conditions such as heart failure and certain hormone imbalances. SAMSCA helps raise salt levels in your blood by removing extra body water as urine.It is not known if SAMSCA is safe or works in children.
WARNINGS AND PRECAUTIONS
- Liver Injury - Samsca can cause serious and potentially fatal liver injury. In a placebo-controlled and open label extension study of chronically administered tolvaptan in patients with autosomal dominant polycystic kidney disease, cases of serious liver injury attributed to tolvaptan were observed…