FDA warns against bed-wetting drug

A drug used to control bed-wetting in children can increase the risk of seizures and death, government health regulators warned Tuesday. The Food and Drug Administration warned patients and physicians Tuesday of the risk of possibly fatal seizures linked to desmopressin, a drug that lowers the amount of water eliminated in urine.

The United States’ health agency said that certain patients, including children treated with the intranasal formulation of the drug for primary nocturnal enuresis (PNE), are at risk for developing severe hyponatremia or an abnormally low concentration of sodium in the blood, which can result in seizures and death.

The agency issued the warning after it reviewed 61 reports of people treated with desmopressin that developed seizures related to hyponatremia. Of the total 61 cases of seizures, two people of 28 and 80 years of age died, said Susan Cruzan, FDA’s spokeswoman.

"The direct contribution of desmopressin to the deaths is unclear," the FDA said in a notice posted on agency’s Website.

Manufactured by Sanofi-Aventis, desmopressin is sold by several companies, including privately held Ferring Pharmaceuticals, under the names DDAVP Nasal Spray, DDVP, DDAVP Rhinal Tube, Stimate Nasal Spray and Minirin.

FDA said that nasal versions of desmopressin intranasal formulations, involving nasal spray, are no longer approved to prevent bed-wetting in children, and asked physicians and patients to take these indications into consideration.

"All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia," the FDA said.

The agency has requested manufacturers to change the labeling on the drug's nasal-drop formulations to include that the drug is not approved for use in young children to prevent bed wetting. FDA also urged the drug makers to include important new information about severe hyponatremia and seizures in the proposed revised label, and also state that desmopressin should no longer be used by patients with a history of sodium deficiency.

Moreover, the revised desmopression tablets’ label would also advise patients to stop using the drug if they experience vomiting, diarrhea or other conditions that lower fluid levels.

Desmopressin is a synthetic analogue of vasopressin, an antidiuretic hormone that helps to prevent or control frequent urination, excessive thirst, and dehydration associated with decreased levels of vasopressin.

The drug limits the amount of water that's eliminated in urine, and is still approved to treat excessive thirst, urination and dehydration caused by injury, surgery and certain medical conditions.