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US FDA Updates Desmopressin Acetate Prescribing Information


December 04, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), has requested the manufacturers update the prescribing information for desmopressin to include important new information about severe hyponatremia and seizures.

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. 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.

General Recommendations and Considerations :

 Desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis due to serious hyponatremia that may result in seizures and death. Doctors should consider other options for managing this condition.

 Desmopressin tablets :

Ø Treatment for primary nocturnal enuresis should be interrupted during episodes of fluid and/or electrolyte imbalance , such as fever, recurrent vomiting or diarrhea, vigorous exercise, or other conditions associated with increased water consumption.

Ø Fluid intake should be restricted from 1 hour before to 8 hours after administration of desmopressin tablets

 All desmopressin formulations should be used cautiously in patients with habitual or psychogenic polydipsia or in patients who are taking drugs that may cause them to drink more fluids, such as tricyclic antidepressants and selective serotonin re-uptake inhibitors (SSRIs). Patients taking desmopressin and consuming excessive fluids are at higher risk of developing hyponatremia

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions of desmopressin to the National Pharmacovigilance center on the internet at: