Approval of Samsca
The U.S. Food and Drug Administration approved Samsca tablets (tolvaptan) on May 22, 2009
to treat hyponatremia, an abnormally low concentration of sodium in the blood.
Samsca is approved to treat hyponatremia associated with congestive heart failure, liver
cirrhosis, and the syndrome of inappropriate antidiuretic hormone secretion.
When sodium levels drop in the fluid outside of cells throughout the body, water moves into cells
to balance the sodium levels and causes the cells to swell. Swelling of the brain cells is thought
to cause many of the symptoms of hyponatremia. Those symptoms may include fatigue,
weakness, headache, nausea, confusion or decreased consciousness, and convulsions. Severe
hyponatremia, which has not been studied with Samsca, can lead to coma and death.
Samsca helps raise sodium levels in the blood by removing extra body water in the urine.
Patients using the drug in clinical trials had a greater degree of increase in sodium levels in the
blood compared with patients taking a pill containing no active drug (placebo).
Side Effects Warning
Samsca is being approved with a boxed warning to alert health care professionals and patients
that the drug should be started only in a hospital where blood sodium can be monitored closely.
Too rapid a rise in sodium can cause a serious condition called osmotic demyelination
syndrome (ODS). ODS can lead to coma or death and can also cause symptoms such as
trouble speaking, trouble swallowing, drowsiness, confusion, mood changes, seizures and
trouble controlling body movement with muscle weakness in the arms and legs.
Although no cases of ODS were seen in clinical trials of Samsca, ODS is a known risk and it is
essential that physicians be aware of it and avoid rapid rises in sodium. Additionally, the FDA is
requiring a Risk Evaluation and Mitigation Strategy that requires a patient Medication Guide be
given out when the drug is dispensed. The Medication Guide will provide information about the
drug’s benefits and risks.
The most common adverse reactions or unwanted side effects with use of Samsca reported by
patients in clinical trials include thirst, dry mouth, weakness, constipation, making large amounts
of urine, urinating often, and increased blood sugar levels.
Samsca is marketed by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.
FDA Approves Samsca to Treat Hyponatremia FDA News Release May 22, 2009
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