The U.S. Food and Drug Administration (FDA) recently warned that the diuretic drug Samsca (tolvaptan) may cause liver problems in certain patients. The FDA recommended that the drug should not be used by patients who have underlying liver disease, including cirrhosis. The FDA also recommended that Samsca should not be used by any patient for longer than 30 days, because the medication may cause liver problems, including liver failure.
Samsca is currently approved only for the treatment of hyponatremia, a condition in which unusual water retention causes low levels of sodium in the blood. The increased risk of liver injury was discovered in a recent clinical trial that was evaluating the use of Samsca for treatment of autosomal dominant polycystic kidney disease (ADPKD).
The FDA has required the drug’s manufacturer, Otsuka Pharmaceutical Company, to revise the Samsca drug label to include new restrictions on its use.
The FDA has warned healthcare providers that treatment with Samsca should be stopped immediately if a patient develops any signs of liver disease. Signs of liver disease include:
- Loss of appetite
- Unusual fatigue
- Yellowing of the skin
- Yellowing of the whites of the eyes
- Darkening of the urine
- Pain or discomfort in the right upper stomach area
Anyone experiencing these side effects is encouraged to see a physician immediately. Patients who suffer Samsca liver damage should contact the FDA at www.fda.gov/MedWatch/report.htm or at 800-332-1088.
If you have suffered liver damage or liver failure as a result of using Samsca, you may be eligible to take part in an Illinois class action lawsuit against Otsuka Pharmaceutical Company. To learn more about how a Samsca class action lawsuit can help you get compensation for your medical bills, lost income and other damages, contact the Gurnee drug injury lawyers at Hupy and Abraham by calling 800-800-5678.