Alert issued for nocturnal enuresis drug

December 21, 2007

Children who are being treated for primary nocturnal enuresis (PNE) with desmopressin intranasal formulations are especially susceptible to severe hyponatremia, which can lead to seizures, brain swelling, and death.

Children who are being treated for primary nocturnal enuresis (PNE) with desmopressin intranasal formulations are especially susceptible to severe hyponatremia, which can lead to seizures, brain swelling, and death.

The Food and Drug Administration is warning health care providers that these 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.”Medications are marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray.

PNE treatment with desmopressin tablets should be suspended during illnesses, vigorous exercise, or other conditions that may lead to an imbalance of fluids and/or electrolytes. Patients should also restrict fluid intake from one hour before to eight hours after taking desmopressin tablets.The agency is asking drug manufacturers to update the prescribing information for desmopressin to include this new information. The alert can be accessed at www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm