Enuresis indication removed from DDAVP due to hyponatremia

December 6, 2007

Intranasal desmopressin no longer indicated for PNE

The FDA has requested manufacturers of intranasal desmopressin to stop marketing the formulation for the treatment of primary nocturnal enuresis (PNE) after receiving 61 postmarketing reports of hyponatremic-related seizures associated with use of the drug. Fifty-five cases had reported sodium levels ranging from 104-130 mEq/L during the seizure event, and two patients died. Thirty-six cases were associated with the intranasal formulation. The agency suggests that physicians consider other options for managing the condition. Desmopressin tablets can still be used to treat PNE; however, it is recommended that treatment be interrupted during episodes of fluid and/or electrolyte imbalance such as fever, vomiting, diarrhea, or vigorous exercise. In addition, fluid intake should be restricted from one hour before to eight hours after administration of desmopressin tablets. All desmopressin formulations should be used cautiously in patients at risk for water intoxication—e.g., patients with habitual or psychogenic polydipsia or patients taking tricyclic antidepressants and selective serotonin reuptake inhibitors.

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