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Samsca (Tolvaptan): Drug Safety Communication - FDA Limits Duration and Usage Due To Possible Liver Injury Leading to Organ Transplant or Death


AUDIENCE: Pharmacy, Health Professional, Patient

ISSUE: FDA has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. FDA has worked with the manufacturer to revise the Samsca drug label to include new limitations.

BACKGROUND: Samsca is a selective vasopression V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca for a new use in patients with autosomal dominant polycystic kidney disease (ADPKD).

RECOMMENDATION: Samsca treatment should be stopped if the patient develops signs of liver disease. Treatment duration should be limited to 30 days or less, and use should be avoided in patients with underlying liver disease, including cirrhosis. Patients should be aware that Samsca may cause liver problems, including life-threatening liver failure, and should contact their health care professional to discuss any questions or concerns about Samsca.

Read the MedWatch safety alert, including links to the Drug Safety Communication, prescribing information, and previous MedWatch safety alert at:

FDA決議Samsca (tolvaptan) 不應使用超過30天以上,且因此藥可能會造成肝臟損害,導致須肝臟移植或死亡,故不建議用於具有肝臟疾病之病人。FDA已與廠商一同將新的建議加入Samsca仿單中。

Samsca為選擇性作用於血管加壓素V2受器之拮抗劑,用於治療臨床上顯著之高容積與正常容積的低血鈉症,包含有心衰竭或抗利尿激素不適當分泌症候群之 病人。目前於一項評估此藥使用於自體顯性遺傳之多囊腎疾病 (ADPKD) 病人之大型臨床試驗中,發現此藥可能會增加肝臟損害之風險。


[Posted 04/30/2013]