FDA Approves Samsca To Treat Hyponatremia
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The U.S. Board and Narcotic Governance has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood.
"With the approval of Samsca, physicians will bear an supplementary effects to treat hyponatremia," said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDA's Centre for Drug Evaluation and Research.
Samsca is approved to treat hyponatremia associated with congestive heart failure, liver cirrhosis , and the syndrome of inappropriate antidiuretic hormone secretion.
When sodium levels blop in the fluid away of cells throughout the body, soak moves into cells to balance the sodium levels and causes the cells to swell. Swelling of the brain cells is thought to create crowded of the symptoms of hyponatremia. Those symptoms may admit fatigue, weakness, headache, nausea, confusion or decreased consciousness, and convulsions. Severe hyponatremia, which has not been studied with Samsca, can margin to coma and death.
Samsca helps stand sodium levels in the blood by removing extra reason water in the urine. Patients using the drug in clinical trials had a greater measure of increase in sodium levels in the blood compared with patients taking a pill containing no active drug (placebo).
Samsca is existence approved with a boxed warning to alert health worry professionals and patients that the drug should be started isolated in a hospital where blood sodium can be monitored closely. Very rapid a rise in sodium can cause a genuine case called osmotic demyelination syndrome (ODS). ODS can example to coma or passing away and can besides cause symptoms such as dire straits speaking, matter swallowing, drowsiness, confusion, mood changes, seizures and bother controlling oppose movement with muscle weakness in the arms and legs.
Although no cases of ODS were seen in clinical trials of Samsca, ODS is a acknowledged risk and it is essential that physicians be aware of it and avoid rapid rises in sodium. Additionally, the FDA is requiring a Risk Trial and Mitigation Strategy that requires a patient Medication Bird dog be inclined out when the drug is dispensed. The Medication Guide testament provide enlightenment approximately the drug's benefits and risks.
The most characteristic adverse reactions with advantage of Samsca reported by patients in clinical trials combine thirst, dry mouth, weakness, constipation, forging large amounts of urine, urinating often, and increased blood sugar levels.
Samsca is marketed by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.
U.S. Bite and Drug Administration
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