January 25, 2013 – The widely-prescribed hyponatremia drug Samsca (generic: tolvaptan) has recently been linked to severe liver injuries, according to a warning issued today by the U.S. Food & Drug Administration (FDA). In a recent clinical trial involving a cohort of approximately 1400 patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD), at least three individuals treated with Samsca developed significant increases in serum alanine aminotransferase (ALT) with concomitant. Most of the liver complications associated with Samsca occurred during the first year and a half of therapy with the drug.
Free Samsca Lawsuit Evaluation: If you or a loved one suffered a serious liver injury after taking Samsca, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Samsca and we can help.
What’s the problem?
In the Samsca clinical trial, the maximum daily dose of the drug was 120 mg. (90 mg. in the morning and 30 mg. in the afternoon), which is much higher than the maximum 60 mg. daily dose for which it is approved to treat hyponatremia. Once the test subjects with liver enzyme abnormalities stopped taking Samsca, all three patients improved. An independent panel of liver experts concluded that all three cases of liver injury were likely to have been caused by Samsca.
Manufactured and marketed by Otsuka America Pharmaceutical, Inc., Samsca belongs to a class of drugs known as selective vasopressin V2-receptor antagonists, which are indicated for the treatment of severe cases of hypervolemic and euvolemic hyponatremia. Drugs from this class reduce hormones that regulate the balance of water and salt (sodium) in the body. High levels of these hormones can cause an imbalance that results in low sodium levels and fluid retention. Samsca has not been approved for the treatment of ADPKD, and any use of the drug for this purpose is done so ‘off-label.’
The results of the trial suggest that Samsca has the potential to cause life-threatening liver injuries. The FDA is advising healthcare providers to perform liver tests in patients who display symptoms of hepatic injury, which may include:
- right upper abdominal discomfort
- dark urine
If liver injury is suspected, treatment with Samsca should be discontinued immediately, appropriate therapy should be implemented, and an investigation to determine the cause of the complication should be conducted. Treatment with Samsca should not be re-initiated unless the source of the injury is determined to be unrelated to the drug.
Samsca Side Effects
In addition to having the potential to cause severe liver injuries, Samsca has also been reported to cause the following side effects in certain users:
- allergic reactions (hives; difficult breathing; swelling of the face, lips, tongue, or throat)
- problems with speech or muscle control
- trouble swallowing
- trouble moving arms and legs
- mood changes
- seizure (convulsions)
- weakness or fainting
- black, bloody, or tarry stools
- coughing up blood or vomit that looks like coffee grounds
- dry mouth
- increased thirst or urination
- loss of appetite
- fruity breath odor
- dry skin
Do I Have a Samsca Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Samsca lawsuits. We are handling individual litigation nationwide and currently accepting new Samsca liver injury cases in all 50 states.
Free Samsca Lawsuit Evaluation: If you or a loved one suffered a serious liver injury after taking Samsca, you should contact our law firm immediately. You may be entitled to compensation by filing a Samsca liver injury suit and we can help.