FDA Warns Samsca Users of the Risk of Liver Damage

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On May 22, 2009, the U.S. Food and Drug Administration approved Samsca as a treatment for hyponatremia. This medication, marketed by Otsuka Pharmaceuticals, has been known for its ability to effectively and rapidly restore proper sodium and fluid levels in the body. However, recent reports express that Samsca may pose hazardous risks to the liver.

After conducting a double-blind study on patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD), the FDA concluded that in some cases, Samsca can increase certain liver enzymes called serum alanine aminotransferase or “ALT” to dangerous amounts. As of January 25, 2013, both the FDA and Otsuka have released a statement to all patients taking Samsca as a treatment, highlighting the serious risk for hepatic (liver) injury.

According the press release, the FDA urges patients to schedule frequent appointments to test their liver function. If you notice symptoms of liver damage, contact your healthcare provider at once. Side effects may include:

• severe drowsiness or fatigue
• pain in the upper right section of the abdomen
• jaundice (yellowing of the skin or eyes)
• color that appears darker than usual
• anorexia, rapid weight loss, and insufficient food intake

Before taking Samsca, consult your doctor to ensure that this medication is safe for you. Discuss treatment options for your medical condition as well as the benefits and risks of taking Samsca. Patients with pre-existing liver damage or liver disease (especially cirrhosis) may be advised not to take Samsca.

Learn more information on U.S. Food and Drug Administration news and medical information at Bad-drug.net.