Bed-Wetting Drug Linked to Severe Hyponatremia, FDA Warns

Food and Drug Administration warned patients and physicians Tuesday that desmopressin, a drug used to control bed-wetting in children could increase the risk of seizures and death.

The health agency gave the warning after it received 61 reports of seizures, two of them being fatal, among patients using desmopressin. The drug is prescribed for lowering the amount of water eliminated in urine.

Desmopressin is designed to limit the amount of water eliminated via urine and is used to prevent and control excessive thirst, urination and dehydration caused by injury, surgery and certain medical conditions including a form of diabetes.

The FDA said that certain patients using the drug risk developing hyponatremia, also known as an abnormally low concentration of sodium in the blood, which can lead to seizures and deaths.

According to the FDA, children being treated with intranasal forms of desmopressin for bed-wetting or primary nocturnal enuresis (PNE) were “particularly susceptible to severe hyponatremia and seizures.”

Desmopressin is currently sold under the names DDAVP Nasal Spray, DDAVP Rhinal Tube, DDVP, Minirin and Stimate Nasal Spray and Sanofi-Aventis is one of the several companies producing them.

Doctors should consider other ways for treating hyponatremia, said the warning issued by the FDA’s Center for Drug Evaluation and Research.

The FDA said desmopressin intranasal formulations, involving nasal spray, are no longer approved to control bed-wetting in children.

Other formulations of desmopressin such as tablet, rhinal tube and injection forms of desmopressin will also have warning information about the risk for hyponatremia, said the FDA.

All patients using desmopressin and ingesting excessive fluids are at higher risk of developing hyponatremia, warned the FDA.

Labels on desmopression tablets should also advise patients to stop using the drug if they experience vomiting, diarrhea or other conditions that lower fluid levels.