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Title: FDA Alert: Desmopressin Acetate Linked to Seizures, Death in Children With PNE
URL: http://www.pslgroup.com/dg/218776.htm
Doctor's Guide
December 4, 2007

ROCKVILLE, MD -- December 4, 2007 -- FDA has requested the manufacturers update the prescribing information for desmopressin to include important new information about severe hyponatremia and seizures.

Certain patients taking desmopressin are at risk for developing severe hyponatremia that can result in seizures and death. Children treated with desmopressin intranasal formulations for primary nocturnal enuresis (PNE) are particularly susceptible to severe hyponatremia and seizures. As such, desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis and should not be used in hyponatremic patients or patients with a history of hyponatremia. PNE treatment with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid and/or electrolyte imbalance. All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.


SOURCE: US Food and Drug Administration

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