Desmopressin - Risk of Hyponatremia and Seizures
December 6, 2007
FDA warned healthcare professionals and patients of the increased risk of severe hyponatremia and seizures in patients taking desmopressin. Because of this risk, FDA has requested the following changes to the prescribing information of desmopressin:
- Intranasal desmopressin is no longer indicated for primary nocturnal enuresis (PNE)
- In patients taking desmopressin tablets for PNE, interrupt therapy during acute illness to decrease risk of electrolyte imbalance
- Instruct patients to restrict fluid intake 1 hour before and 8 hours after taking desmopressin tablets
- Use all desmopressin formulations with caution in patients at risk for water intoxication (e.g., psychogenic polydipsia, patients taking concurrent medications that may cause dry mouth)
- Intranasal desmopressin should not be used in patients with hyponatremia or with a history of hyponatremia
Inform patients and parents of children taking desmopressin about the risks of hyponatremia, the importance of limiting water intake, and the symptoms of hyponatremia.
Additional information is available at the following links:
- MedWatch Alert:
- Information for Health Care Providers:
- Desmopressin product information:
12/6/2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.