FDA Links Samsca to Liver Injury

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FDA Links Samsca to Liver Injury

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In a recent Safety Announcement, the U.S. Food and Drug Administration (FDA) announced 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 death.

Samsca is a prescription drug used to treat low sodium levels in the blood. 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 .

Signs and Symptoms of liver problems include:

Loss of appetite, nausea, vomiting
Fever, feeling unwell, unusual tiredness
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

The FDA has worked with the manufacturer to revise the Samsca drug label to include these new limitations. The Samsca drug label has been updated to include the following information:

• Limitation of the duration of Samsca treatment to 30 days. (Dosage and Administration and Warnings and Precautions sections)

• Removal of the indication for use in patients with cirrhosis, a condition that involves scarring of the liver due to injury or long-term disease. Use of Samsca in patients with underlying liver disease, including cirrhosis, should be avoided because the ability to recover from liver injury may be impaired.

• Description of liver injuries seen in clinical trials of patients with autosomal dominant polycystic kidney disease (ADPKD).

• Recommendation to discontinue Samsca in patients with symptoms of liver injury.

If you or someone you know has been injured by Samsca, call Longo Legal, PLLC to find out if you have a potential claim. The first step is to get some preliminary information over the phone. The initial phone call and consultation cost you nothing. You will not pay Longo Legal, PLLC anything towards your Samsca lawsuit unless a recovery is made on your behalf. Call Longo Legal at (855) 566-4648 to see if you qualify.

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