Samsca Gets Revised Label to Reflect its Potential to Cause Serious Liver Damage

samca_revised_labelTaking the drug Samsca (tolvaptan) for more than a month could cause serious liver injury or even death, according to federal health officials. Also at risk is anyone who has an underlying kidney problem and takes the drug.

The U.S. Food and Drug Administration (FDA) is working with the maker of Samsca to update the drug’s warning label to take this risk into account. The FDA also released its own statement, saying that no one should take the drug for more than 30 days and that treatment should cease if signs of liver injury are apparent. Thise with liver disease, such as cirrhosis, should also avoid Samsca, the FDA said in its statement.

Overall, the FDA noted that Samsca carries a risk of liver injuries as well as of liver failure, a fatal condition.

Reviewing the results of a clinical trial by which Samsca was tested as a treatment for autosomal dominant polycystic kidney disease (ADPKD) caused the regulator to decide to take action. It has been reported that fatigue, anorexia, upper abdominal discomfort, dark urine, and signs of jaundice are among the symptoms experienced by those who could be suffering from kidney problems while taking Samsca.

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