On April 30, 2013, the U.S. Food and Drug Administration (FDA) published new guidelines for the use of Samsca (Tolvaptan), a drug used to treat hyponatremia, a condition that causes low levels of sodium in the blood. The new guidelines come after a clinical study linked the use of the drug to elevated levels of enzymes associated with liver damage.
Samsca is produced and marketed by Otsuka Pharmaceutical Company. The drug has been approved for the treatment of hyponatremia since 2009 with few reports of side-effects. Otsuka was conducting a clinical study to determine whether the drug could be used for the treatment of patients with autosomal dominant polycystic kidney disease (ADPKD). On January 22, 2013, the drug company released a letter alerting health care providers that they had discovered a link between the use of Samsca and liver injury. In response, the FDA has put restrictions on the drug.
The FDA has determined:
- Samsca should not be used for longer than 30 days.
- Samsca should not be used in patients with underlying liver disease, including cirrhosis. These patients may not be able to recover from liver damage caused by Samsca.
- Patients with suspected liver injury should stop taking Samsca immediately.
- Doctors should perform liver function tests on any patients taking Samsca who report fatigue, jaundice, dark urine, abdominal pain, anorexia and other signs of liver injury.
The FDA is working with Otsuka Pharmaceutical Company to revise the Samsca drug label to include these new restrictions.
More than 4,500 patients are taking the drug. If you are one of these patients and have experienced signs of liver failure, you may be eligible to take part in an Illinois class action lawsuit against Otsuka Pharmaceutical. To learn more about Illinois drug injury claims, please contact the Gurnee personal injury lawyers at Hupy and Abraham at 800-800-5678.