Desmopressin gains warning, loses indication

The FDA has requested the labeling for all desmopressin products be updated to include new information about severe hyponatremia and seizures. Certain patients, including children treated with intranasal desmopressin for primary nocturnal enuresis (PNE), are at risk for developing severe hyponatremia that may result in seizures and death.

As a result of these warnings, the desmopressin intranasal formulations are no longer indicated for the treatment of PNE and should not be used in hyponatremic patients or patients with a history of hyponatremia. Also, PNE treatment with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid and/or electrolyte imbalance. All formulations of this antidiuretic hormone should be used cautiously in patients consuming excessive fluids due to a higher risk of hyponatremia.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079928.htm.