Desmopressin Acetate to get New Warning for Severe HyponatremiaDec 4, 2007 | Parker Waichman LLP
The manufacturers of Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin and Stimate Nasal Spray) have been asked by the Food & Drug Administration (FDA) to update the labels for these medications to include new information about the risk of patients taking Desmopressin developing side effects that include severe hyponatremia and seizures.
Desmopressin Acetate is a medication that takes the place of Antidiuretic hormone (ADH), which is normally made and released from the pituitary gland. The main role of ADH is to decrease the amount of urine made by the kidneys. Formulations of Desmopressin Acetate can be used to control Diabetes Insipidus or to treat primary nocturnal enuresis (night time bedwetting). Desmopressin Acetate is also used before dental and minor surgical procedures by people who have mild to moderate hemophilia to help increase clotting factors.
According to the FDA notice, some people being treated with Desmopressin are at risk for developing severe hyponatremia, an electrolyte disturbance that occurs when the body's sodium levels become too low. Desmopressin works by limiting the amount of water eliminated in urine. A body needs to maintain a balance of water and salt to stay healthy. Desmopressin can upset this balance, leading to hyponatremia, seizures, and in some extreme cases, death. Typical symptoms of hyponatremia include nausea, vomiting, headache and malaise. As the hyponatremia worsens, confusion, diminished reflexes, convulsions, stupor or coma may occur. This can result in seizures and death. The FDA says that children treated with intranasal Desmopressin formulations for bedwetting appear to be particularly vulnerable to this side effect.
The new Desmopressin labeling says that intranasal formulations of the drug are no longer indicated for the treatment of primary nocturnal enuresis and should not be used in hyponatremic patients or in patients with a history of hyponatremia. Treatment of night time bedwetting with Desmopressin tablets should be interrupted during illnesses that may lead to fluid or electrolyte imbalance. Patients should restrict fluid intake from 1 hour before to 8 hours after taking Desmopressin tablets. Finally, the FDA is warning that all Desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.
Doctors should tell parents of children taking Desmopressin to monitor their water intake, and to contact the physician if the child's water intake suddenly changes. Desmopressin patients should also know that a person's chance of a water and sodium imbalance is increased during hot weather or strenuous exercises; when they have a severe cold, the flu or any illness that results in vomiting, diarrhea or fever; or by taking certain drugs, like antidepressants, anti-seizure medications and painkillers that may leave a patient with a dry mouth. Patients, or the parents of patients using Desmopressin should inform their doctor of other medications they are taking, or if they have a history of hyponatremia. Desmopressin patients should seek medical attention if they experience any of the signs of hyponatremia, including nausea, vomiting, fatigue, muscle cramps or weakness.