Samsca is a medication manufactured by Otsuka America Pharmaceutical and is approved for hyponatremia, a metabolic condition in which there is not enough sodium (salt) in the body fluids outside the cells. According to a recent Drug Safety Communication, the U.S. Food and Drug Administration (FDA) has determined that “the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. [The] FDA has worked with the manufacturer to revise the Samsca drug label to include new limitations.”
A prior Drug Safety Communication was issued by the FDA in January 2013, stating that Samsca has been linked to potentially irreversible and fatal liver injury. The communication also states that doctors should perform liver tests on Samsca patients who report symptoms indicating liver injury.
A clinical trial of Tolvaptan on patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) has shown that use of Samsca may lead to abnormally high levels of liver enzymes; these findings prompted the company to issue a letter to healthcare providers warning that Samsca may cause irreversible and potentially fatal liver injury. If you or a loved one developed a liver injury after taking Samsca, our attorneys would like to speak with you. Call Parker Waichman LLP today for a free, no-obligation evaluation of your case.
Clinical Trials Show Samsca® May Cause Potentially Fatal Liver Injury in ADPKD
On January 22, 2013 Otsuka America Pharmaceutical issued a letter to healthcare providers warning of significant liver injury associated with the use of Samsca. This warning was based on a 3-year clinical trial of some 1,400 patients with ADPKD; three of these patients developed levels of serum alanine aminotransferase (ALT) that were three times as high as the upper limit of normal as well as serum total bilirubin levels more than twice the upper limit of normal. Alanine aminotransferase (ALT) is an enzyme found in the liver and bilirubin is waste product of the normal breakdown of red blood cells; the levels of these substances are measured in order to assess liver damage and injury. According to the letter, the three cases are “probably or highly likely to be caused by tolvaptan,” suggesting that “Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.”
The letter also said that patients taking Samsca had significantly higher levels of ALT compared to those taking a placebo. In 4.4 percent (42 out of 958) of ADPKD patients taking Samsca, ALT levels were three times higher than the upper limit of normal compared to the 1 percent (5 out of 958) of patients on placebo. After discontinuing Samsca, the affected patients gradually improved, the letter said.
Samsca is not approved for ADPKD; it is approved for the treatment of clinically significant hypervolemic or euvolomic hyponatremia, or low levels of sodium in the blood. Although previous findings have not indicated liver damage with the use of Samsca in the past, Otsuka states that this data is inadequate to rule out the possibility that Samsca increases the risk of irreversible and potentially fatal liver injury. Furthermore, the company’s letter said that the ability to recover from such injury may be inhibited in patients with hyponatremia “in the setting of underlying liver disease, including cirrhosis”.
Liver Injury Symptoms
Otsuka’s letter states that healthcare professionals should perform tests to assess liver function in Samsca patients who report symptoms of liver injury, including:
- Right upper abdominal discomfort
- Dark urine
- Jaundice (yellowing of the skin and/or eyes)
If liver injury is suspected, Otsuka said, “Samsca should be promptly discontinued, appropriate treatment should be instituted, and investigations should be performed to determine probable cause.”
Legal Help for Victims of Samsca Side Effects
If you or a loved one suffered from a liver injury after taking Samsca, you may have valuable legal rights. Please fill out our online form or call 1(800)-YOURLAWYER (1-800-968-7529) to speak with one of our experienced drug injury lawyers today.