Tap To Call: 727-451-6900

Samsca Linked to Serious Liver Damage

Doctors prescribe  tovlaptan (Samsca) to treat patients with hyponatremia, when their blood sodium level is low. Hyponatremia can be caused by a variety of circumstances, and in severe cases lead to confusion and/or seizures. However, the danger of SAMSCA’s side-effects may out outweigh its benefit.

On April 30, the U.S. Food and Drug Administration (FDA) issued a safety announcement, warning against long-term usage or high dosage of Samsca, citing serious repercussions to the liver that could lead to future organ transplant or death. The FDA warning came three months after the pharmaceutical company that manufactures Samsca, Otsuka America Pharmaceutical, Inc., released a letter to healthcare providers warning of significant liver injury associated with prolonged use of the kidney drug.

Otsuka America Pharmaceutical, Inc. released its January 22, 2013 letter in response to the results it obtained from three years of clinical trials. The  purpose of the testing was to determine any negative effects Samsca could cause. Over 1400 patients suffering from Autosomal Dominant Polycystic Kidney Disease (ADPKD) used Samsca in double-blind, placebo-controlled clinical tests. These tests were conducted over the course of three years.

According to the FDA, Samsca “should not be used for longer than 30 days and should not be used in patients with underlying liver disease.”

After conducting clinical tests on the effects of the drug, the FDA and Otsuka America Pharmaceutical, Inc. revised the Samsca’s warning label to include the following information:

  • Limitation of the duration of Samsca treatment to 30 days. (Dosage and Administration and Warnings and Precautions sections)
  • Removal of the indication for use in patients with cirrhosis, a condition that involves scarring of the liver due to injury or long-term disease. Use of Samsca in patients with underlying liver disease, including cirrhosis, should be avoided because the ability to recover from liver injury may be impaired. (Indications and Usage and Use in Specific Populations sections)
  • Description of liver injuries seen in clinical trials of patients with autosomal dominant polycystic kidney disease (ADPKD).
  • Recommendation to discontinue Samsca in patients with symptoms of liver injury.

If a person suffers not only from hyponatremia but also an underlying liver disease, Samsca has the potential to cause life-threatening liver injury. Samsca may impair a person’s ability to recover from liver injury. In an effort to protect the people that use this medication, Otsuka America and the FDA instruct physicians to limit the duration of treatment in order to reduce the risk of possible liver injury. Indicia of livery injury include right upper abdominal pain, abdominal swelling or tenderness, difficulty breathing, blood in the urine or stool, nausea, vomiting, lightheadedness, faintness, fatigue, jaundice, rapid heart rate, and low blood pressure.

If a person taking Samsca has any of these symptoms, then physicians test for liver injury. If the tests indicate that liver injury is the suspected cause, the FDA recommends promptly discontinuing the use of Samsca, initiating hepatic treatment, and further investigating the cause of the symptoms. Only after Samsca is definitively eliminated as the cause of the symptoms should a patient resume the Samsca treatment.

For more information on claims involving Samsca, Risperdal, Mirena IUD and Actos among other defective drugs call the dangerous medication attorneys at the Sibley Dolman Gipe Accident Injury Lawyers, PA for a free consultation and case evaluation. (833) 606-DRUG [3784].