Bed-Wetting Drug May Cause Seizures or Death, FDA Says
Patients taking desmopressin acetate risk developing hyponatremia, an abnormally low concentration of sodium in the blood, which can result in seizures and death, the FDA said in a MedWatch alert.
The product is marketed by sanofi-aventis as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP and DDVP, while Ferring Pharmaceuticals uses the trade name Minirin and CSL Behring markets it as Stimate Nasal Spray.
The FDA notified endocrinologists, pediatricians, other healthcare professionals and patients that it has asked the manufacturers to update the prescribing information for the drug to include new safety information about hyponatremia and seizures.
Desmopressin intranasal formulations are no longer indicated for treating bed-wetting and should not be used in patients with a history of hyponatremia, the FDA said.
Additional information can be found at www.fda.gov/cder/drug/InfoSheets/HCP/desmopressinHCP.htm.