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FDA Warns Samsca Use May Lead to Serious Liver Damage

May 2, 2013

Data from some large clinical trials prompted the U.S. Food and Drug Administration (FDA) to announce that Samsca may cause liver damage.

The study found that Samsca (tolvaptan) should be used no longer than 30 days in patients with no underlying liver disease and should never be used by patients diagnosed with underlying liver disease, said Renal & Urology News.

A selective vasopression V2-receptor antagonist, Samsca is indicated for the treatment of patients who are diagnosed with hypervolemic and euvolemic hyponatremia. Hypervolemic and euvolemic hyponatremia are electrolyte disturbances in which the body suffers from a lower-than-normal sodium ion concentration in the serum.

In trials evaluating Samsca in patients with autosomal dominant polycystic kidney disease, Samsca was shown to increase risks for liver injury, said Renal & Urology News. Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disorder in which many cysts form in the kidneys, causing the kidneys to become enlarged. Samsca is not FDA-approved for the treatment of ADPKD.

Samsca’s manufacturer, Otsuka, and the FDA will be updating the drug label to reflect the revised information.

According to the FDA, "Samsca treatment should be stopped if the patient develops signs of liver disease. Treatment duration should be limited to 30 days or less, and use should be avoided in patients with underlying liver disease, including cirrhosis.

“Patients should be aware that Samsca may cause liver problems, including life-threatening liver failure, and should contact their health care professional to discuss any questions or concerns about Samsca."

Otsuka previously said that patients taking Samsca who are diagnosed with underlying liver disease that may cause or contribute to hyponatremia may be less able to recover from drug-induced liver injury. Otsuka recommended healthcare providers order liver tests for any patient taking Samsca with symptoms consistent with hepatic (liver) injury:

  • Fatigue
  • Anorexia
  • Discomfort in the upper, right abdomen
  • Dark urine
  • Jaundice.

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