Contact us 24/7

Samsca

Samsca and Liver Damage

[ATTENTION] On January 25, 2013 the U.S. Food and Drug Administration (FDA) issued a warning stating that Samsca (Tolvaptan) can cause potentially deadly liver damage. Samsca (Tolvaptan) is manufactured by Osaka Pharmaceuticals and was approved by the FDA in 2009 for the treatment of hyponatremia, an abnormally low concentration of sodium in the blood.

According to the FDA approval letter, “Samsca is approved to treat hyponatremia associated with congestive heart failure, liver cirrhosis, and the syndrome of inappropriate antidiuretic hormone secretion.”

FDA ISSUES WARNING ON SAMSCA AND LIVER DAMAGE

  • The FDA released a warning on January 25, 2013 notifying healthcare professionals of significant liver injury associated with the use of Samsca.
  • The warning was based on findings from a double-blind, 3-year, placebo-controlled trial on Samsca.
  • During the trial, 3 patients treated with the drug developed liver damage.
  • An external panel of liver experts assessed these 3 cases as being either “probably or highly likely to be caused by tolvaptan.”
  • The panel concluded that Samsca (tolvaptan) has “the potential to cause irreversible and potentially fatal liver injury.”
SAMSCA PATIENTS REPORT MORE THAN 700 ADVERSE EVENTS TO FDA

According to DrugCite.com, an online resource which pulls data from the United States Food and Drug Administration’s (US FDA) Adverse Event Reporting System (AERS), there have been more than 700 adverse events reported by patients taking Samsca.  Adverse events reported include:

  • Hypernatraemia and Hyponatraemia
  • Renal Impairment
  • Liver Disorder
  • Heart Disorder
  • Congestive Heart Failure
  • Death

HAVE YOU BEEN INJURED?

If you’ve been injured, we can help. Contact us