| Samsca |
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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.
Indication
Samsca is approved to treat hyponatremia associated with congestive
heart failure, liver cirrhosis, and the syndrome of inappropriate
antidiuretic hormone secretion.
Hyponatremia
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.
Action
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.
Source:
FDA Approves Samsca to Treat Hyponatremia FDA News Release May
22, 2009
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.
Indication
Samsca is approved to treat hyponatremia associated with congestive
heart failure, liver cirrhosis, and the syndrome of inappropriate
antidiuretic hormone secretion.
Hyponatremia
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.
Action
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.
Source:
FDA Approves Samsca to Treat Hyponatremia FDA News Release May
22, 2009
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PHYTONUTRIENTS AND DRUG PRODUCTS. THIS WEBSITE ALSO TALKS ABOUT SOME POPULAR HEALTH ISSUES AND DISEASES.
ARTICLES IN THIS WEB SITE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, YOU SHOULD CONSULT WITH YOUR
DOCTOR IMMEDIATELY. ALL RIGHTS RESERVED 2008. DO NOT COPY NOR TRANSFER ARTICLES TO OTHER WEBSITES NOR OTHER
FORMS OF PUBLICATIONS. Privacy Policy. ARTICLE INDEX
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