Safety Alerts & Recalls

What does this mean?

Samsca is used for the treatment of hyponatremia (low sodium in the blood) and changes to your treatment should not be made without first consulting your doctor or other healthcare professional. If you take Samsca, please follow up with your healthcare provider to discuss this new safety information and the limits to the use of Samsca.

Also, please be aware that Samsca may cause liver problems, including life-threatening liver failure. Contact your healthcare provider right away if you take Samsca and experience any of these signs and symptoms of liver problems:

-- Loss of appetite, nausea, vomiting

-- Fever, feeling unwell, unusual tiredne

-- Itching

-- Yellowing of the skin or the whites of the eyes (jaundice)

-- Unusual darkening of the urine

-- Pain or discomfort in the right upper abdomen, where the liver is located

Please contact your healthcare provide if you have any questions about Samsca or any of your other medications.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Updates Prescribing Information for Samsca: Limits Use

The U.S. Food and Drug Administration (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 requiring liver transplant or causing death. The prescribing information for Samsca will be updated to include these new limits to its use.

For more information, please visit: more information here

Source: FDA
Publication Date: 2013-05-01
Last Updated: 2013-05-01

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