January 25, 2013 — The U.S. Food and Drug Administration (FDA) has published a Safety Communication to warn about the risk of liver injury associated with Samsca (tolvaptan). This drug is used to treat a medical condition in which a patient has too much fluid in the blood and too little sodium. The drug’s manufacturer, Otsuka America Pharmaceutical, has also sent a “Dear Healthcare Provider” to physicians with a warning about liver injury.
In the letter, Otsuka warned:
“An external panel of liver experts assessed these three cases as being either probably or highly likely to be caused by tolvaptan. These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.”
The link between Samsca and liver injury was discovered during a 3-year clinical trial in which about 1400 patients ere given the maximum daily dose of Samsca (90-mg in the morning and 30-mg in the afternoon). This is higher than the 60-mg dose that is approved to treat fluid retention and low sodium levels. Of the 1400 patients who were given high-dose Samsca, 3 patients developed “significant” increased liver enzyme levels. All three of the patients improved after they discontinued the drug.
The clinical trials also found that Samsca patients had higher levels of ALT, which is a liver enzyme that is released when the liver is damaged. ALT levels were 3-times higher than the upper limit of “normal” in 42 out of 958 patients given Samsca, compared to just 5 of 484 patients given a placebo.
Otsuka and the FDA warned that patients with underlying liver problems could be less likely to recover from Samsca induced liver injury, which could potentially lead to liver failure and death.
According to the FDA, symptoms of liver injury include:
- Right upper abdominal discomfort
- Dark urine
- Jaundice (yellowing of the skin and/or eyes)
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