FDA requests new prescribing information for desmopressin

December 20, 2007

The FDA has requested that manufacturers update the labels and prescribing information for tablet and intranasal formulations of desmopressin (DDAVP, Minirin, Stimate), used to treat pediatric nocturnal enuresis, to include important new information about the risk of severe hyponatremia and seizures. The action follows reports of 61 patients who experienced hyponatremia-related seizures linked to use of the drug, including two who died.

The FDA has requested that manufacturers update the labels and prescribing information for tablet and intranasal formulations of desmopressin (DDAVP, Minirin, Stimate), used to treat pediatric nocturnal enuresis, to include important new information about the risk of severe hyponatremia and seizures. The action follows reports of 61 patients who experienced hyponatremia-related seizures linked to use of the drug, including two who died.

Children treated with desmopressin intranasal formulations for primary nocturnal enuresis are particularly susceptible to severe hyponatremia and seizures. As such, desmopressin intranasal formulations are no longer indicated for bed wetting, and should not be used in hyponatremic patients or patients with a history of hyponatremia.

Primary nocturnal enuresis treatment with desmopressin tablets should be interrupted during acute illnesses accompanied by fever or recurrent vomiting or diarrhea and in healthy patients who exercise vigorously or who have other conditions that may lead to fluid and/or electrolyte imbalance, according to an FDA announcement. All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.