The U.S. Food and Drug Administration has issued a warning to healthcare professionals that the drug Samsca — used to raise sodium levels in the blood of people with heart disease and liver problems — “has the potential to cause irreversible and potentially fatal liver injury.”
Samsca (Tolvaptan) is a drug used to treat hypervolemic and euvolemic hyponatremia — a lack of salt in body fluids.
The FDA’s warning was made along with Otsuka America Pharmaceutical Inc., which distributes and markets the drug Samsca, after liver injury was found in patients treated with the drug as part of a large clinical trial. Three of the 1,400 patients in the study experienced increases in liver enzymes, which may indicate serious liver damage, mostly during the first 18 months of the three-year study.
Samsca is a prescription medicine used to help increase low sodium levels in the blood in adults with conditions such as heart failure, liver disease and certain hormone imbalances.
FDA experts advised anyone who has taken Samsca to consult a doctor about any of the following symptoms of liver injury: tiredness, anorexia, abdominal discomfort, dark urine, or yellowing of the skin.
The FDA recommended healthcare providers perform liver tests promptly for patients taking the drug who report symptoms and, if damage is confirmed, discontinue its use.
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