Printer Friendly

Intranasal desmopressin tied to hyponatremia.

Intranasal formulations of desmopressin acetate are no longer indicated for treating primary nocturnal enuresis because of the risk of severe hyponatremia and seizures associated with these products when used for this indication, according to the Food and Drug Administration.

"Doctors should consider other options for managing this condition" because certain patients who are taking desmopressin are at risk for developing severe hyponatremia that can result in seizures and death, according to an alert that was issued by the FDA.

The FDA reviewed 61 postmarketing reports of hyponatremic-related seizures associated with the use of desmopressin, including two deaths. In 55 of the cases, sodium levels ranged from 104 mEq/L to 130 mEq/L during the seizure. Both patients who died had hyponatremia and seizures, "but the direct contribution of desmopressin to the deaths is unclear," the advisory said.

Of the 61 patients included in the analysis, 39 also had at least one concomitant disease or were on at least one drug that was also associated with hyponatremia and/or seizures.

Children with primary nocturnal enuresis treated with intranasal formulations of desmopressin are "particularly susceptible" to seizures and severe hyponatremia.

Of the 61 cases, 36 were associated with intranasal formulations, of which 25 cases were in children and adolescents younger than 17 years. Nocturnal enuresis was the most commonly reported reason for using desmopressin in these 25 pediatric cases.

Desmopressin is a synthetic analogue of the antidiuretic hormone vasopressin.

Other recommendations in the advisory include the following:

* Desmopressin products should not be used in patients who have hyponatremia or in those who have a history of hyponatremia.

* All desmopressin formulations "should be used cautiously" in patients who are at risk for water intoxication with hyponatremia.

These include patients with habitual or psychogenic polydipsia or patients who take medication-such as tricyclic antidepressants and SSRIs--that may increase their fluid intake.

* Treatment of primary nocturnal enuresis with desmopressin tablets should be interrupted during vigorous exercise; any acute illness that can result in fluid and/or an electrolyte imbalance, such as fever, recurrent vomiting, or diarrhea; or other conditions that can result in increased intake of water.

* Fluid intake needs to be restricted during a period starting 1 hour before and ending 8 hours after a patient takes a desmopressin tablet.

The agency has asked desmopressin manufacturers to update the label of their products to include the information about hyponatremia risk and how to safely use desmopressin.

Desmopressin acetate is marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, Minirin, and Stimate nasal spray, according to the FDA.

The full advisory, which includes information for patients, is available at: www.fda.gov/medwatch/safety/2007/safety07.htm#Desmopressin. Unexpected or serious adverse events associated with this drug should be reported to the FDA's MedWatch program at 800-332-1088 or www.fda.gov/medwatch.

BY ELIZABETH MECHCATIE

Senior Writer
COPYRIGHT 2008 International Medical News Group
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2008 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Author:Mechcatie, Elizabeth
Publication:Internal Medicine News
Geographic Code:1USA
Date:Feb 1, 2008
Words:472
Previous Article:Modern evidence lacking on phenylephrine dosages.
Next Article:Bystolic.
Topics:


Related Articles
Desmopressin (DDAVP). (Medication Update).
SSRI-induced hyponatremia underrecognized.
SSRI-induced hyponatremia underrecognized in elderly.
Desmopressin may ease nocturia.
Hyponatremia due to an additive effect of carbamazepine and clarithromycin.
Hyponatremia during exercise: act promptly.
Desmopressin (dDAVP) incident signals the need for enhanced monitoring protocols.
FDA warns about serious effects of intranasal desmopressin.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters