Samsca Lawsuit

Samsca (tolvaptan) has been associated with an increased risk of liver failure, which may require a liver transplant or cause death. The link between Samsca and liver injury is especially concerning for patients at risk of liver disease, but anyone can be injured. Our lawyers are now accepting Samsca lawsuits because the warnings regarding this severe, life-threatening side effect were inadequate.

What You Can Do & How a Samsca Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting Samsca induced injury cases in all 50 states. If you or somebody you know was injured by Samsca, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

UPDATE: FDA Safety Warning for Samsca and Liver Failure

April 30, 2013 — In a new Safety Announcement, the U.S Food and Drug Administration (FDA) has issued this recommendation:

“Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant or death.”

January 25, 2013 — After a study linked Samsca and “significant liver injury,” the FDA published this Drug Safety Communication to warn about the link between Samsca and liver failure. Click here to read more.

What is Samsca?

Samsca (tolvaptan) is a medication that helps balance excessively low concentrations of salt (sodium) in the bloodstream by inducing urination, which removes extra body water. This treats a condition called hyponatremia.

Samsca was developed by the drug company Otsuka, and it was approved by the FDA in 2009. It belongs to a class of drugs known as selective vasopressin V2-receptor antagonists, which help balance levels of salt and water by influencing the hormones that regulate blood chemistry.

Study of Samsca and Liver Failure

Researchers first found an association between Samsca and liver failure after conducting a 3-year, placebo-controlled study of Samsca in approximately 1,400 people with kidney disease. Samsca is not FDA-approved to treat patients with kidney disease.

Unfortunately, three patients in the study developed “significant” symptoms of liver damage — including elevated liver enzymes (ALT) and bilirubin in their blood. Experts determined that Samsca “probably or highly likely” caused these injuries.

When researchers checked other patients for liver injury, they found that 42 out of 948 patients (4.4%) on high-dose Samsca (120mg per day) had elevated liver enzyme levels that were 3X higher than the upper-limit of “normal.” Only 1% of the patients on a placebo had the same symptoms of liver injury.

After the study was published, the FDA warned:

“These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.”

The manufacturer, Otsuka, also warned in a “Dear Doctor” letter:

“The ability to recover from liver injury may be impaired in patients with … underlying liver disease, including cirrhosis.”

Symptoms of Liver Injury from Samsca

Samsca patients and their doctors should be aware of the symptoms of liver injury. The FDA recommends that Samsca should be discontinued if a liver injury occurs. Furthermore, it should not be used in patients at high risk of liver disease.

Symptoms of liver injury include:

• Fatigue
• Anorexia (weight-loss, loss of appetite)
• Abdominal pain (upper-right side)
• Urine is dark, cola-colored, or amber
• Jaundice (yellowing of skin or whites of the eyes)

Samsca Side Effects

The Prescribing Information warns about the risk of many life-threatening Samsca side effects, including:

• Liver side effects: These side effects include liver failure, which will require a transplant and potentially lead to death.
• Osmotic demyelination syndrome: This side effect is included in a “Black Box Warning,” which is the most serious type of warning. It occurs when sodium levels are increased too quickly.
• Gastrointestinal bleeding: This side effect was seen in 10% of patients who had pre-existing cirrhosis of the liver.
• Dehydration: Samsca causes excessive urination, which can deplete fluid volume in the body. Dehydration occurred in 3.3% of patients in clinical trials.
• Hypovolemia and hypovolemic shock: This side effect occurs as a complication of dehydration, when there is not enough water for normal blood volume, and the heart is unable to circulate blood or oxygen in the body.
• Hyperkalemia (high potassium): This can occur when fluid loss cause an imbalance of potassium levels in the blood. It can interfere with electrical activity in the heart and cause life-threatening arrhythmias.

Common Samsca side effects include:

• Urination is excessively frequent or high-volume
• Dry mouth
• Constipation
• Thirst
• Weakness
• Fever
• Elevated blood-sugar levels (hyperglycemia)
• Anorexia (weight-loss, lack of appetite)

Do I have a Samsca Lawsuit?

The Schmidt Firm, PLLC is currently accepting Samsca induced injury cases in all 50 states. If you or somebody you know was injured by Samsca, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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