Label Changes for:
Samsca (tolvaptan) Tablets
Changes have been made to the CONTRAINDICATIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
4.6 Hypersensitivity…section added
- Immune System Disorders: Hypersensitivity reactions including anaphylactic shock and rash generalized [see Contraindications (4.6)].
Who should not take Samsca?, the following bullet was added:
- you are allergic to tolvaptan or any of the ingredients in SAMSCA. See the end of this Medication Guide for a complete list of ingredients in SAMSCA.
'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…