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In December 2007, the US Food and Drug Administration (FDA) announced that it had requested manufacturers of desmopressin acetate to update prescribing information to include information concerning the risk for developing severe hyponatremia, which can result in seizures and death. Desmopressin nasal spray (acetate intranasal formulation) is no longer indicated for treatment of bed-wetting (primary nocturnal enuresis).
The FDA advisory was issued based on a review of 61 postmarketing cases of hyponatremia-related seizures associated with the use of desmopressin. In two of the cases, the patients experienced hyponatremia that led to seizures and death.
Hyponatremia is an electrolyte disturbance characterized by a low sodium concentration in blood plasma. At these low sodium levels, overhydration (water intoxication), an urgently dangerous condition, may result.
Desmopressin tablets may still be used to treat primary nocturnal enuresis (PNE). But according to MedWatch, the FDA's safety information and adverse event reporting program, the therapy should be discontinued during acute illness that can lead to electrolyte and/or fluid imbalance. Fluid intake should also be restricted one hour prior to eight hours after dose administration. All formulations of desmopressin should be used cautiously in patients at risk for hyponatremia. These risk factors include events or conditions that increase water consumption, such as:
- Dry mouth (as may occur when other medications are taken concurrently)
- Recurrent diarrhea/vomiting
- Vigorous exercise
- Hot weather
- Psychogenic or habitual polydipsia (drinking abnormally large amounts of fluid)
- Use of tricyclic antidepressants or SSRIs
In 64 percent of the postmarketing hyponatremia cases referenced above, the patient had at least one condition or used a drug that predisposed him or her to hyponatremia or seizures.
Desmopressin Acetate is marketed by Sanofi-Aventis as DDAVP, Ferring Pharmaceuticals as Minirin, and CSL Behring as Stimate. In its various forms and modes of administration, it is indicated to manage several other conditions, including:
- antidiuretic replacement therapies for central cranial diabetes insipidus
- temporary polyuria (excessive volume of urine)
- polydipsia following surgery/head trauma in the pituitary region
- to stop or prevent excessive bleeding in patients with hemophilia A
- certain cases of mild to moderate classic von Willebrand's disease
Regardless of the treatment for which desmopressin is used, healthcare workers are urged to warn caregivers and patients with regard to the need to monitor water intake.
Adverse effects should be reported to MedWatch at 1-800-FDA-1088 or on their website at www.fda.gov/medwatch. You may also consider contacting an experienced pharmaceutical injury attorney prior to when any statutes of limitation apply (deadlines by which you may file a claim) to find out if you may be entitled to compensation.