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LIVER FAILURE LINKED TO EXTENDED USE OF TOLVAPTAN

Samsca (tolvaptan) is a pharmaceutical drug prescribed to treat hyponatremia (low blood sodium levels) in patients with congestive heart failure or SIADH (syndrome of inappropriate antidiuretic hormone). Manufactured by Otsuka Pharmaceutical Co., tolvaptan was approved by the FDA and introduced to the market in 2009.

Tolvaptan is a vasopressin receptor antagonist, which increases the amount of urine created in the body. Normal levels of sodium can return to the body as extra water is expelled. Side effects associated with Samsca include:

  • Dry mouth
  • Loss of appetite
  • Weakness
  • Constipation
  • Thirst
  • Dehydration

FDA WARNS OF LIVER INJURY AFTER SAMSCA USAGE

In 2013, the FDA determined that Samsca should not be used for longer than 30 days because it can cause liver injury that may require a liver transplant or death. In addition, the agency warns that patients with underlying liver disease or susceptibility to liver disease should refrain from taking the drug. A clinical trial evaluating Samsca in patients with polycystic kidney disease revealed three cases of severe liver injury attributed to the drug. The earliest case of severe liver injury in this trial was found three months after treatment began.

Symptoms of liver injury include:

  • Loss of appetite
  • Fever
  • Right upper stomach area pain
  • Itching
  • Yellowing of the skin (jaundice)
  • Unusual tiredness
  • Vomiting
  • Nausea
  • Darkening of the urine

Other changes were made to the Samsca drug label by the FDA. The drug is no longer indicated for use in patients with cirrhosis, due to the increased risk of causing liver injury. Patients suffering from cirrhosis may not be able to recover from the injury.

RAPID CORRECTION OF LOW SODIUM LEVELS CAN CAUSE COMA AND DEATH

Samsca’s black box warning warns patients that a too rapid correction of hyponatremia can cause severe complications. Patients are urged to start and re-start treatment in a hospital where their sodium levels can be monitored. One side effect of a hastily risen blood sodium level is osmotic demyelination syndrome (ODS). This syndrome can cause seizures, coma, and even death.

Symptoms of ODS include:

  • Trouble speaking
  • Drowsiness
  • Confusion
  • Mood changes
  • Trouble controlling body movement
  • Weakness in muscles of the extremities

ODS can lead to serious conditions, including dysarthria, mutism, dysphagia, lethargy, and affective changes as well.

CONTACT AN EXPERIENCED PHARMACEUTICAL LITIGATION ATTORNEY

If you or a loved one has suffered a severe side effect from taking the dangerous drug Samsca, you may be entitled to compensation. The drug has been linked to many serious side effects that could potentially be life-threatening. At Thomas J. Henry, we have the legal and financial resources necessary to take on pharmaceutical companies. Our experienced dangerous drug attorneys are available 24/7, nights and weekends to evaluate your claim. Contact us today.

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