The U.S. Food and Drug Administration has asked the manufacturers to update drug labels and prescription information on desmopressin, available in tablet and nasal spray form and used to treat bed wetting, to include new information about severe hyponatremia, a condition caused by insufficient sodium in the blood which leads to seizures and sometimes death.
The FDA announcement explained that certain patients taking desmopressin (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray), were at risk of "developing severe hyponatremia that can result in seizures and death."
Desmopressin reduces water elimination via urine, thus preventing excessive thirst, urination and dehydration brought about by a range of conditions such as types of diabetes, physical injury and surgery.
Children who were being treated with intranasal forms of desmopressin for bed wetting or primary nocturnal enuresis (PNE) were "particularly susceptible to severe hyponatremia and seizures" said the FDA.
The warnings and restrictions apply differently to the nasal spray and other formulations of desmopressin.
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- Special Features staff report