Bed-wetting drug desmopressin warning issued by FDA
Risk of seizures, death; drug could cause an abnormally low concentration of sodium
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On December 4, 2007, the Food and Drug Administration (FDA) issued a safety alert for desmopressin, a generic drug used to treat night-time bed-wetting. The agency said certain patients are at risk of developing hyponatremia, which is an abnormally low concentration of sodium in the blood that can cause seizures and death.
The FDA has indicated that intranasal formulations of the drug, like nasal spray, are no longer approved for children because kids are especially susceptible to the risk of severe hyponatremia, and seizures. Alternative formulations of desmopressin (i.e., tablets) are still approved, however new warnings and treatment guidelines have been issued.
The following are the names of the affected formulations of the drug:
Desmopressin works by limiting the amount of water eliminated in urine. A healthy body needs to maintain a balance of water and salt and if sodium levels fall, an imbalance is created that may lead to seizures, brain swelling, and even death.
The FDA issued the warning after reviewing 61 postmarketing cases of seizures related to hyponatremia associated with desmopressin. In two cases, the patients died.
Sources: “Information for healthcare professionals: desmopressin acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray),” United States Food and Drug Administration Safety Alert, December 4, 2007; Jennifer Corbett Dooren, “FDA warns of seizure risk with drug used for bed-wetting,” Wall Street Journal, December 4, 2007.
