March 2008: FDA Alert Requests that Prescribing Information for Desmopressin Be Updated with New Information
Following a review of 61 postmarketing cases of hyponatremia-related seizures associated with administration of desmopressin, the US Food and Drug Administration (FDA) issued an alert and asked manufacturers to update the prescribing information for this drug to include important new information about severe hyponatremia and seizures.The FDA advises: “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.”
The complete alert is available from:
http://www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm
