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Samsca FDA Alerts

The FDA Alert(s) below may be specifically about Samsca or relate to a group or class of drugs which include Samsca (tolvaptan).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for tolvaptan

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

Apr 30, 2013

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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[04/30/2013 - Drug Safety Communication - FDA]
[04/09/2013 - Samsca (Tolvaptan) Prescribing Information - Otsuka]

Samsca (tolvaptan): Drug Warning - Potential Risk of Liver Injury

Jan 25, 2013

Audience: Gastroenterology, Nephrology, Pharmacy

ISSUE: Otsuka and FDA notified healthcare professionals of significant liver injury associated with the use of Samsca. In a double-blind, 3-year, placebo-controlled trial in about 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and its open-label extension trial, 3 patients treated with the drug developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. In the trials the maximum daily dose of Samsca administered (90 mg in the morning and 30 mg in the afternoon) was higher than the maximum 60 mg daily dose approved for the treatment of hyponatremia.

Most of the liver enzyme abnormalities were observed during the first 18 months of therapy. Following discontinuation of treatment, all 3 patients improved. An external panel of liver experts assessed these 3 cases as being either probably or highly likely to be caused by tolvaptan. These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury. These data are not adequate to exclude the possibility that patients receiving Samsca for its indicated use of clinically significant hypervolemic and euvolemic hyponatremia are at a potential increased risk for irreversible and potentially fatal liver injury.

BACKGROUND: Samsca is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia. Samsca is not approved for the treatment of ADPKD.

RECOMMENDATION: Healthcare providers should perform liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. If hepatic injury is suspected, Samsca should be promptly discontinued, appropriate treatment should be instituted, and investigations should be performed to determine probable cause. Samsca should not be re-initiated in patients unless the cause for the observed liver injury is definitively established to be unrelated to treatment with Samsca.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[01/22/2013 - Dear Healthcare Provider Letter - Otsuka]
[11/2012 - Samsca (tolvaptan) Prescribing Information - Otsuka]
[11/2012 - Samsca (tolvaptan) Medication Guide - Otsuka]

More Samsca Resources