Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. All lots of DDAVP® Nasal Spray 10 mcg/0.1 ml, Desmopressin Acetate nasal Spray 10 mcg/0.1 ml, and STIMATE® Nasal Spray 1.5 mg/ml listed in the table are recalled.
Exposure to higher than expected amounts of desmopressin may result in hyponatremia which may lead to seizure, coma, and death. The manufacturer has no known reports of adverse events associated with the superpotent product during the affected timeframe.
Desmopressin is a synthetic analog of the antidiuretic hormone arginine vasopressin and works by increasing adenosine monophosphate (cAMP) in renal tubular cells, increasing water permeability, and decreasing urine volume and increasing urine osmolarity. Additionally, desmopressin increases plasma levels of von Willebrand factor, Factor VIII, and t-PA.
Desmopressin nasal products are indicated for use in a variety of conditions such as an antidiuretic therapy in the management of central cranial diabetes insipidus, temporary polyuria and polydipsia following head trauma, pituitary surgery, hemophilia A with Factor VIII coagulant activity levels greater than 5%, or mild to moderate classic von Willebrand disease (Type 1) with Factor VIII activity levels greater than 5%.
Patients and healthcare providers can report any adverse reaction related to superpotent desmopressin nasal products to the FDA’s MedWatch program in 1 of 2 ways.
- Submit a report online at www.fda.gov/medwatch/report.htm
- Complete a paper form and fax to 1-800-FDA-0178
Additional information is available at the following links: