Samsca Lawsuit Information
Recently, the hyponatremia drug Samsca® (tolvaptan) manufactured by Otsuka American Pharmaceuticals, Inc. has been linked to severe liver damage. Though the drug has not been recalled by the United States Food and Drug Administration, a recently-published clinical trial has revealed that three subjects experienced liver damage. As stated in a Samsca® warning letter issued by the manufacturer on in January regarding the risk of liver damage associated with Samsca® use “An external panel of liver experts assessed these 3 cases as being either probably or highly likely to be caused by tolvaptan. These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.”
Tolvaptan is a drug that aims to elevate levels of sodium in the blood by blocking stopping certain receptors in the brain from taking in arginine vasopressin, a neurophysiological hormone that “plays a key role in homeostasis, by the regulation of water, glucose, and salts in the blood.”
Here is an excerpt from the page on Samsca® from the prominent online medical encyclopedia curated by the US National Library of Medicine, MedlinePlus:
“Tolvaptan may cause the level of sodium in your blood to increase too quickly. This may cause osmotic demyelination syndrome (ODS; serious nerve damage that may be caused by quick increases in sodium levels). Tell your doctor if you drink or have ever drunk large amounts of alcohol, if you have malnutrition (the body lacks the nutrients needed for good health), and if you have or have ever had liver disease or extremely low levels of sodium in your blood.
You and your doctor will take certain precautions to try to prevent ODS. You will begin your treatment with tolvaptan in the hospital so that your doctor can monitor you closely. If your doctor tells you to continue taking tolvaptan after you leave the hospital, you should not stop and re-start treatment on your own. You will need to return to the hospital when you restart the medication.
You will need to drink water whenever you are thirsty to help prevent ODS during your treatment with tolvaptan. Your doctor will not prescribe tolvaptan if you are unable to feel that you are thirsty. You should have drinking water available at all times during your treatment.
If you experience any of the following symptoms of ODS, tell your doctor immediately: difficulty speaking, difficulty swallowing, feeling that food or drinks are getting stuck in your throat, drowsiness, confusion, mood changes, body movements that are difficult to control, weakness of the arms or legs, or seizures.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with tolvaptan and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.”
The rest of the page regarding Samsca on the MedlinePlus website may be found by following the link above.
The United States National Library of Medicine writes that if one experiences the following symptoms, one ought to contact a healthcare professional immediately.
- inability to drink normally
- vomit that is bloody or looks like coffee grounds
- bloody or black and tarry stools
And, if the following set of symptoms are “severe or do not go away,” one ought also to contact one’s physician:
- dry mouth
- frequent, excessive urination
- loss of appetite
Other important information regarding Samsca and its safety may be found here:
- Tolvaptan (Samsca) for Hyponatremia: Is It Worth Its Salt?
- FDA Limits Use of Samsca (Tolvaptan) Due to Liver Injury Risk
- FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death
- Tolvaptan – Wikipedia