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Tolvaptan Approved for Use in Hyponatremia
The FDA has approved tolvaptan tablets for use in hyponatremia associated with heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone secretion.
The drug, a vasopressin-receptor antagonist, will be dispensed with a boxed warning that it only be started in hospitals, where sodium levels can be monitored closely. If sodium levels rise too quickly, osmotic demyelination syndrome can result.
It will be marketed as Samsca in the U.S.
LINK(S):
FDA news release (Free)
2006 NEJM study of tolvaptan (Free)
Journal Watch General Medicine coverage of NEJM study (Your Journal Watch subscription required)
Published in Physician's First Watch May 26, 2009
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