Samsca (tolvaptan) is a medication that helps balance sodium levels in the blood. Unfortunately, recent studies have linked Samsca to severe, life-threatening liver failure — especially for people with pre-existing liver disease or cirrhosis of the liver. Our Texas Samsca lawyers are concerned because patients who were prescribed this medication may not have been adequately warned about the risk of Samsca and liver failure.
Need a Texas Samsca Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by Samsca, you should contact our lawyers immediately. You may be entitled to compensation by filing a Samsca lawsuit in Texas.
UPDATE: FDA Warning for Samsca and Liver Failure
April 30, 2013 — The U.S. Food and Drug Administration (FDA) has published a Safety Announcement to warn:
“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 — The FDA and Otsuka, the manufacturer of Samsca (tolvaptan), have published a Drug Safety Communication to warn about the potential risk of “significant liver injury.” Click here to read more.
What is Samsca?
Samsca (tolvaptan) is a medication that treats hyponatremia, or an abnormally low concentration of salt (sodium) in a patient’s blood. It is manufactured by Otsuka and was approved by the FDA in 2009.
Samsca helps raise sodium levels in the blood by removing extra body water in the urine. It is a type of drug known as a selective vasopressin V2-receptor antagonist, which works by influencing hormones that balance salt and water.
Study of Samsca and Liver Failure
The link between Samsca and liver failure was first identified in a 3-year, placebo-controlled study in about 1,400 people with kidney disease. After three patients developed symptoms of liver damage, a panel of liver experts determined that the cases were “probably or highly likely” caused by Samsca.
Evidence linking Samsca and liver failure increased when researchers found that 4.4% of patients (42 out of 958) developed elevated levels of liver enzymes (ALT) greater than 3X the upper-limit of “normal.” In comparison, only 1% of patients on a placebo (5 out of 484) developed elevated ALT levels.
According to the FDA:
“These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.”
Most of the patients gradually improved after discontinuing Samsca. However, according to this “Dear Doctor” letter published by Otsuka, “the ability to recover from liver injury may be impaired in patients with … underlying liver disease, including cirrhosis.”
Symptoms of Liver Injury from Samsca
Experts recommend that Samsca should not be used in patients with pre-existing liver disease, and Samsca should be discontinued if a liver injury occurs. Therefore, doctors and patients should be vigilant for the following symptoms of liver injury:
- 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
According to the Samsca Prescribing Information, Samsca is associated with many life-threatening side effects, including:
- Liver side effects: Including liver failure and the need for a transplant
- Osmotic demyelination syndrome: Samsca has a “Black Box Warning” for this side effect, which is caused by a too-rapid elevation of sodium levels in the blood.
- Gastrointestinal bleeding: This side effect is most likely to occur in patients with cirrhosis of the liver (approximately 10% of patients). Samsca is now contraindicated in patients with cirrhosis.
- Dehydration: Samsca causes excessive urination, which can lead to dehydration (fluid-volume depletion in the body). In clinical trials, dehydration occurred in 3.3% of patients. It is more likely to occur in patients on fluid-restriction diets.
- Hypovolemia / hypovolemic shock: Severe fluid loss (excessive urination, for example) decreases blood volume and makes the heart unable to pump enough blood into the body.
- Hyperkalemia (excessive potassium in the blood): Samsca reduces fluid in the blood, which can increase the level of potassium to life-threatening levels.
The most common Samsca side effects include:
- Urination is excessively frequent or high-volume
- Dry mouth
- Elevated blood-sugar levels (hyperglycemia)
- Anorexia (weight-loss, lack of appetite)
Need a Samsca Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas Samsca lawsuit review.