Ferring has announced a recall of 3 products: DDAVP® (desmopressin acetate) Nasal Spray 10mcg/0.1mL, Desmopressin Acetate Nasal Spray 10mcg/0.1mL, and Stimate® (desmopressin acetate) Nasal Spray 1.5mg/mL.
The recall is due to higher than specified amounts of desmopressin in the products. The use of superpotent products containing desmopressin could result in hyponatremia that may eventually lead to serious adverse events such as seizure, coma, and/or respiratory arrest. Symptoms of hyponatremia include headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status (ie, hallucinations, decreased consciousness, confusion).
One nonfatal adverse event has been reported during the timeframe the affected product was distributed and may potentially be connected to increased concentrations of desmopressin; however the Company noted there has not been an increase in adverse event reporting related to this issue. A list of affected lots can be found here.
Adverse events related to this recall should be reported to FDA’s MedWatch Adverse Event Reporting program.
DDAVP® Nasal Spray and Desmopressin Acetate Nasal Spray, both antidiuretic replacement therapies, are indicated in the management of central diabetes insipidus.
Stimate® Nasal Spray is indicated for the treatment of patients with hemophilia A with Factor VIll coagulant activity levels >5%. It is also approved for the treatment of patients with mild to moderate classic von Willebrand disease (Type I) with Factor VIII levels >5%.
For more information visit fda.gov.
Ferring US issues voluntary nationwide recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL due to superpotency. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate. Accessed August 7, 2020.