FDA notified healthcare professionals and patients of the Agency's request that manufacturers update the prescribing information for desmopressin.  Certain patients, including children treated with the intranasal formulation of the drug for primary nocturnal enuresis (bedwetting), 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 bedwetting and should not be used in hyponatremic patients or patients with a history of hyponatremia. Bedwetting treatment with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid and/or electrolyte imbalance. All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.

This alert applies to the following products:  DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray.

Desmopressin works by limiting the amount of water that is eliminated in the urine.  A healthy body needs to maintain a balance of water and salt (“sodium”).  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.  A person’s chance of water and sodium imbalance is increased

• if they are taking certain medicines such as antidepressants, painkillers, and medicines to treat seizures that may make the mouth dry
• during hot weather or following strenuous exercise that may make them thirsty
• if they are sick and have severe vomiting and diarrhea, fever, the flu, or severe cold

Therefore, if your child is prescribed desmopressin, it is important that you

• tell your doctor about other medicines your child is taking
• tell your doctor if your child has a history of hyponatremia
• supervise the use of desmopressin in your child if it is administered in the nose for the remaining indications
• restrict fluid intake from 1 hour before to 8 hours after taking desmopressin tablets
• promptly contact your doctor if your child’s water intake changes
• promptly contact your doctor if symptoms of hyponatremia occur, such as nausea, vomiting, fatigue, muscle cramps or weakness

Background Information and Data

Desmopressin is a synthetic analogue of vasopressin, an antidiuretic hormone that prevents excessive water loss in the urine.  Desmopressin in combination with excessive fluid consumption can result in hyponatremia, an imbalance between intracellular and extracellular sodium.  This imbalance can lead to seizures, brain swelling, and death. 

FDA has reviewed 61 postmarketing cases of hyponatremic-related seizures associated with the use of desmopressin.  Fifty-five cases reported sodium levels ranging from 104 to 130 mEq/L during the seizure event.   In two cases, the patients died.  Both patients experienced hyponatremia and seizures but the direct contribution of desmopressin to the deaths is unclear.  Thirty-six cases were associated with intranasal formulations, of which 25 cases occurred in pediatric patients (<17 years old).  The most commonly reported indication of use in these 25 pediatric cases was nocturnal enuresis.  Thirty-nine of the 61 cases were associated with at least one concomitant drug or disease that is also associated with hyponatremia and/or seizures.