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FDA Alerts DDAVP Manufacturers of Prescribing Information Change

The National Hemophilia Foundation has learned that the U.S. Food and Drug Administration (FDA) issued an alert on December 4, 2007, for products that contain desmopressin acetate, a synthetic hormone used in drug formulations to treat bed-wetting. The FDA issued a request that all manufacturers of drugs with desmopressin acetate update their prescribing information to include important information about serious side effects, including severe hyponatremia (abnormally low sodium concentration in the blood) and seizures.

Among the list of desmopressin-containing products is Stimate® Nasal Spray indicated for patients with mild hemophilia A and with mild to moderate von Willebrand disease (type 1). It is important to note that prescribing information for Stimate®, which is manufactured by CSL Behring, already included hyponatremia and seizures as two of several potential adverse reactions prior to FDA’s alert.

This issue surfaced after the FDA conducted a post-marketing review of 61 cases of hyponatremic-related seizures associated with the use of desmopressin. In 39 of the 61 cases, use of desmopressin to treat bed-wetting was associated with hyponatremia and/or seizures.

According to the FDA alert, pediatric patients (those younger than 17 years old) treated with desmopressin intranasal formulations to prevent bed-wetting, known as primary nocturnal enuresis, are particularly susceptible to severe hyponatremia and seizures. In light of this, the FDA has stated that 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. Read the entire FDA alert.

For questions concerning Stimate® Nasal Spray contact your healthcare provider or CSL Behring at 800.683.1288.

Source: FDA Alert dated December 4, 2007


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