Ellen
03-11-2008, 03:10 PM
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=73#6
Potentially Fatal Hyponatremia from Desmopressin
FDA is notifying healthcare professionals about the risk of potentially fatal hyponatremia in certain patients treated with desmopressin, an antidiuretic that is sometimes used to treat nocturnal enuresis (bedwetting). It works by reducing water loss in the urine.
FDA has reviewed 61 reports of hyponatremic seizures associated with the use of desmopressin. Twenty-five cases occurred in children taking the drug intranasally, most of them for bedwetting. Because of this, the intranasal form of desmopressin is no longer indicated for treating nocturnal enuresis. It should not be used for any indication in hyponatremic patients or those with a history of hyponatremia.
Patients taking desmopressin who consume excessive fluids are at higher risk of developing hyponatremia. And so all forms of desmopressin should be used cautiously in patients with polydipsia and in patients taking drugs that may cause increased fluid intake. When using desmopressin tablets, fluid intake should be restricted starting one hour before taking the drug and continuing for 8 hours afterwards.
Interrupt treatment for nocturnal enuresis if the patient significantly increases water intake, or when fluid or electrolyte imbalance are apt to occur, as with fever, recurrent vomiting, diarrhea or vigorous exercise.
Patients or their caregivers should watch for circumstances that could lead to excessive fluid intake, again such as fever, vomiting, diarrhea and strenuous exercise, but also during hot weather and when taking certain medications that produce dry mouth. They should contact their doctor if symptoms of hyponatremia occur, such as severe headache, confusion, nausea, vomiting, fatigue, muscle cramps or weakness.
Additional Information:
FDA MedWatch Safety Alert. Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray). December 4, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Desmopressin (http://www.fda.gov/medwatch/safety/2007/safety07.htm#Desmopressin)
Potentially Fatal Hyponatremia from Desmopressin
FDA is notifying healthcare professionals about the risk of potentially fatal hyponatremia in certain patients treated with desmopressin, an antidiuretic that is sometimes used to treat nocturnal enuresis (bedwetting). It works by reducing water loss in the urine.
FDA has reviewed 61 reports of hyponatremic seizures associated with the use of desmopressin. Twenty-five cases occurred in children taking the drug intranasally, most of them for bedwetting. Because of this, the intranasal form of desmopressin is no longer indicated for treating nocturnal enuresis. It should not be used for any indication in hyponatremic patients or those with a history of hyponatremia.
Patients taking desmopressin who consume excessive fluids are at higher risk of developing hyponatremia. And so all forms of desmopressin should be used cautiously in patients with polydipsia and in patients taking drugs that may cause increased fluid intake. When using desmopressin tablets, fluid intake should be restricted starting one hour before taking the drug and continuing for 8 hours afterwards.
Interrupt treatment for nocturnal enuresis if the patient significantly increases water intake, or when fluid or electrolyte imbalance are apt to occur, as with fever, recurrent vomiting, diarrhea or vigorous exercise.
Patients or their caregivers should watch for circumstances that could lead to excessive fluid intake, again such as fever, vomiting, diarrhea and strenuous exercise, but also during hot weather and when taking certain medications that produce dry mouth. They should contact their doctor if symptoms of hyponatremia occur, such as severe headache, confusion, nausea, vomiting, fatigue, muscle cramps or weakness.
Additional Information:
FDA MedWatch Safety Alert. Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray). December 4, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Desmopressin (http://www.fda.gov/medwatch/safety/2007/safety07.htm#Desmopressin)