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U.S. Department of Health and Human Services

Safety

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Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray)

Audience: Endocrinologists, pediatricians, other healthcare professionals

[UPDATE 8/07/2008] The Dear Healthcare Professional Letter issued by Sanofi-aventis U.S. in December 2007 has been added as a link below. Also, links to prescribing information for healthcare professionals and patient package labeling with the safety-related revisions highlighted are included for the following DDAVP (desmopressin acetate) Sanofi-aventis, U.S. products: Nasal Spray, Rhinal Tube, Injection, and Tablets.

[Posted 12/04/2007] FDA notified healthcare professionals and patients of the Agency's request that manufacturers update the prescribing information for desmopressin to include important new safety information about severe hyponatremia and seizures. Certain patients, including children treated with the intranasal formulation of the drug for primary nocturnal enuresis (PNE), are at risk for developing severe hyponatremia that can result in seizures and death. As such, desmopressin intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis and should not be used in hyponatremic patients or patients with a history of hyponatremia. PNE treatment with desmopressin tablets should be interrupted during acute illnesses that may lead to fluid and/or electrolyte imbalance. All desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia.

[December 04, 2007 - Information for Healthcare Professionals - FDA]
[December 2007 - Dear Healthcare Professional Letter - Sanofi-Aventis]
[October 2007 - DDAVP Injection, Nasal Spray, Rhinal Tube, Tablets - Label - Sanofi-Aventis]