Seizures Prompt New FDA Guidelines for Desmopressin
Drug is linked to severe hyponatremia and subsequent seizures, deaths
WEDNESDAY, Dec. 5 (HealthDay News) -- New prescribing guidelines have been issued for the anti-diuretic drug desmopressin acetate after reviews of 61 cases of hyponatremic-related seizures associated with its use, according to a Dec. 4 announcement from the U.S. Food and Drug Administration.
Of the 61 consumer cases reviewed by the FDA, 55 reported sodium levels ranging from 104 to 130 mEq/L during a seizure event, the FDA said. Two patients died. Intranasal formulations of the drug were involved in 36 of the cases, of which 25 occurred in patients younger than 17. More than half of the cases reviewed were associated with at least one concomitant drug or disease associated with hyponatremia and/or seizures.
Intranasal desmopressin is no longer indicated for treatment of primary nocturnal enuresis, the FDA said, and should not be used in hyponatremic patients or patients with a history of hyponatremia. The announcement also said that treatments with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid and/or electrolyte imbalance, and that all desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.
"Desmopressin works by limiting the amount of water that is eliminated in the urine," according to documents released by the FDA. "If sodium levels fall too much (hyponatremia), a person may have seizures and, in extreme cases, may die. That is why it is important to monitor your or your child's water intake."
Desmopressin is marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray.