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FDA Warning: Liver Damage Linked to Samsca (Tolvaptan)

Karis Rozof4 years ago

On January 25, 2013 the U.S. Food and Drug Administration (FDA) sounded an alarm linking the drug Samsca to increased liver enzymes which can lead to potentially deadly liver damage. This warning came a few days after Samsca’s manufacturer, Otsuka America Pharmaceutical, wrote a letter to healthcare providers warning of the same risks.

What is Samsca (Tolvaptan)?

Samsca is a medication approved by the FDA to treat Hyponatremia, the most common electrolyte disorder in the U.S.

Samsca and Hyponatremia

  • Approximately 6 million patients were diagnosed with Hyponatremia in 2006.
  • This electrolyte deficiency disorder occurs when the sodium level in the blood falls below 135 millequivalents per liter (mEq/L).
  • Normal sodium level is between 135 and 145 mEq/L.

Samsca was approved to treat two types of Hyponatremia

  1. Hypervolemic Hyponatremia: both sodium and water increase in the body with a greater increase in water.
  2. Euvolemic Hyponatremia: normal sodium level with increase in total body water.

Studying Samsca’s Treatment of ADPKD

A trial study was conducted for Samsca’s potential to treat Autosomal Dominant Polycstic Kidney Disease (ADPKD). Samsca is not currently approved in the U.S. for ADPKD.

Samsca Clinical Trial Facts:

  • The trial was a double-blind placebo controlled study.
  • It was conducted over 3 years.
  • It included about 1,400 patients with ADPKD.
  • 3 Samsca patients developed significant increases in the liver enzyme bilirubin
  • Study participants taking Samsca also had 3-times higher than normal level of ALT, which is a liver enzyme that is released when the liver is damaged.
  • 42 out of 958 patients taking Samsca had raised ALT compared to only 5 of 484 given a placebo.
Trial Finds Samsca May Cause Fatal Liver Injury
  • The maximum dose approved for Hyponatremia is 60 mg per day.
  • Samsca’s trial participants were given 120 mg per day: 90 mg in the morning and 30 mg in the afternoon.

These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.” – External Panel of Liver Experts

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