FDA issues alert for DDAVP nasal spray, usage could cause seizures.FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has requested manufacturers update the prescribing information for desmopressin, marketed as DDAVP Nasal Spray, to include important new information about severe hyponatremia Hyponatremia Definition The normal concentration of sodium in the blood plasma is 136-145 mM. Hyponatremia occurs when sodium falls below 130 mM. Plasma sodium levels of 125 mM or less are dangerous and can result in seizures and coma. and seizures, the agency stated in a release Dec. 4. Certain patients taking desmopressin are at risk for developing severe hyponatremia that can result in seizures and death. Children treated with desmopressin intranasal in·tra·na·sal adj. Within the nose. formulations for primary nocturnal enuresis nocturnal enuresis n. See bed-wetting. Nocturnal enuresis Involuntary discharge of urine during the night. Mentioned in: Bed-Wetting nocturnal enuresis Medtalk Bed-wetting, see there (PNE PNE Pine (street suffix) PNE Preston North End (Soccer Club) PNe Planetary Nebulae PNE Pacific National Exhibition PNE Platform for Network Equipment (Wind River) ) are particularly susceptible to severe hyponatremia and seizures. As such, desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis and should not be used in hyponatremic patients or patients with a history of hyponatremia, FDA stated. PNE 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. |
|
||||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion