FDA requests additional warnings for desmopressin

WASHINGTON The Food and Drug Administration has notified health care professionals and patients of its request that manufacturers update the prescribing information for desmopressin. Desmopressin works by mimicking the action of the antidiuretic hormone, which regulates the body’s retention of water.

The new safety information will include the risk for severe hyponatremia, which is water intoxication and seizures.

Certain patients, including children treated with the intranasal formulation of the drug for primary nocturnal enuresis (bed-wetting), are at risk for developing severe hyponatremia that can result in seizures and death. 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. All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.

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