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Home / Uncategorized / FDA Links Samsca to Potential Risk of Liver Injury

FDA Links Samsca to Potential Risk of Liver Injury

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Samsca Liver Injury Risk

A recent warning issued by the FDA urged healthcare providers to discontinue the use of Samsca in patients showing signs of liver injury. According to the agency, patients using the drug Samsca may be at an elevated risk for significant liver injury.

Samsca Liver Injury Study

According to the FDA warning, three of 1,400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who were treated with Samsca developed significant increases in serum alanine aminotransferase (ALT) with concomitant, clinically significant increases in serum total bilirubin. According to the FDA, Samsca (Tolvaptan) is not approved for the treatment of ADPKD.

These findings indicated that Samsca may be related to irreversible and potential fatal liver injury.

Samsca Side Effects

  • Liver injury
  • Fatigue
  • Anorexia
  • Right upper abdominal discomfort
  • Dark urine
  • Jaundice

FDA Samsca Recommendations

The FDA urges healthcare providers to perform liver tests immediately in patients reporting the symptoms listed above. If hepatic injury is suspected, the use of Samsca should be discontinued, appropriate treatment should be instituted, and investigations should be performed to determine the probable cause. Unless the cause for the observed liver injury is determined to be unrelated to the use of Samsca, use of the drug should not be reintroduced.

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