The FDA is warning against using a bed-wetting drug, desmopressin because of a possible link to fatal seizures that have left two dead.
The agency is no longer approving desmopressin be used as a nasal spray to control bed-wetting in children.
The agency says children using the nasal spray are more likely to develop severe hyponatremia which is a dangerously level of low sodium in the blood which can trigger seizures and even death.
The prescription drug is given to limit the quantity of water eliminated in the urine. Desmopressin controls the urge to drink and to urinate and is used to prevent dehydration that can be caused by surgery, an injury or even diabetes.
Taking the drug allows you to sleep through the night without having to urinate.
A healthy body needs to balance water and salt (sodium). The drug not only increases the chance of a water and sodium imbalance but increased complications can result if the patient is taking other medications such as antidepressants, or during hot weather when they may become thirsty, or if they have a fever, severe vomiting or a cold.
Desmopressin also comes in a tablet form and the FDA warns that form of the drug “should be used cautiously” during time of excess fluid intake including a fever or vomiting because of the danger that electrolytes can become imbalanced.
So far the FDA has received 61 adverse events reports of seizures and two deaths among patients ages 80 and 28.
However a direct link of desmopressin to the deaths has not been established. "The direct contribution of desmopressin to the deaths is unclear," the FDA said in a notice.
The synthetic drug has several manufacturers but is known as DDAVP, DDVP, Minirin and Stimate Nasal Spray.
The FDA is asking that the prescribing information be updated by the manufacturers.
Desmopressin does not cure bed-wetting. Most children, 50 to 90 percent relapse after the drug is stopped.