According to a recent safety communication from the U.S. Food and Drug Administration (FDA), Samsca (tolvaptan) may cause liver injury or death. Samsca tablets can be used to treat low sodium levels in patients’ blood, but research indicates that the drug might cause more harm than good. The FDA warns consumers to avoid taking Samsca for more than 30 days. Patients with liver disease should avoid taking the medical at all since recent clinical studies found a strong connection between liver injury and Samsca. Samsca manufacturers and the FDA negotiated an agreement to revise the label for the medication to include the following information:
- A limitation that disallows Samsca treatment for more than 30 days
- A description of liver injuries observed during the clinical trial in kidney disease patients
- A recommendation for patients with liver injuries to discontinue using Samsca
Manufacturers will also remove a recommendation from the label indicating that patients with liver scarring can use to the medication.
What are the side effects of Samsca (Tolvaptan)?
The FDA reports that Samsca consumers may experience symptoms of liver injury such as nausea, vomiting, loss of appetite, fever, fatigue, itching, and jaundice. These signs may indicate more serious conditions, such as liver injury. Without treatment, liver injury can lead to patient death. If you or a loved one experiences any of these conditions, contact your doctor right away; these symptoms could lead to serious organ damage and may require and organ transplant.
California Defective Drugs Lawyers
Although Samsca was approved for use in May, 2009, research shows that the drug may not be safe. Our team of California defective drugs lawyers can help you understand you rights and legal options through a defective drug claim or lawsuit. To learn more, call our office or fill out an online case evaluation form.