Desmopressin Nasal Spray No Longer Indicated for Bed-Wetting

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Desmopressin acetate intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis (PNE) because of the risk for severe hyponatremia that can lead to seizures and death, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday.

These formulations are currently marketed as DDAVP (sanofi-aventis US, LLC), Minirin (Ferring Pharmaceuticals, Inc), and Stimate (CSL Behring, LLC).

The change was based on a review of data from 61 postmarketing cases of hyponatremia-related seizures, 2 of which resulted in death. A large percentage of these cases (41%) occurred in pediatric patients younger than 17 years receiving intranasal desmopressin, most commonly for PNE.

Although desmopressin tablets may still be used for PNE, this therapy should be interrupted during acute illnesses that can lead to fluid and/or electrolyte imbalance, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. Such events can include fever, recurrent vomiting/diarrhea, vigorous exercise, and other conditions that increase water consumption.

The FDA also emphasized that fluid intake should be restricted from 1 hour before to 8 hours following dose administration and that all desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia. Risk factors include habitual or psychogenic polydipsia and use of medications such as tricyclic antidepressants and selective serotonin reuptake inhibitors. Of the 61 postmarketing cases, the majority (64%) occurred in patients with at least 1 factor (drug or disease) predisposing them to hyponatremia or seizures.

Desmopressin nasal spray, rhinal tube, injection, and tablets are indicated as antidiuretic replacement therapies for central cranial diabetes insipidus and for the management of temporary polyuria and polydipsia following head trauma/surgery in the pituitary region.

Desmopressin injection also is indicated to prevent or stop excessive bleeding in patients with hemophilia A and for mild to moderate classic von Willebrand's disease in patients with factor VIII coagulant activity levels more than 5%.

Healthcare professionals are encouraged to warn patients and caregivers regarding the need to monitor water intake while receiving desmopressin therapy, particularly when taking concurrent medications that increase dry mouth, during hot weather or following strenuous exercise that increases thirst, and during periods of illness with severe vomiting/diarrhea or fever.

Adverse events related to use of desmopressin should be communicated to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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