Three weeks after recalling numerous lots of desmopressin nasal sprays in the UK and a number of other countries, Ferring has issued a recall of all lots of DDAVP 10 mcg/0.1ml, Stimate 1.5 mg/ml, and generic desmopressin 10 mcg/0.1ml nasal sprays in the US “due to superpotency or amounts of desmopressin higher than specified.” The recall includes 6 lots of DDAVP, 15 lots of Stimate, and 16 lots of generic desmopressin nasal spray.
DDAVP and the generic desmopressin nasal sprays are used “as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.” The generic nasal spray is marketed by Amring Pharmaceuticals. Stimate, which is marketed by CSL Behring, is indicated for the treatment of bleeding in hemophilia A and von Willebrand’s Disease.
According to the Ferring US recall announcement, “The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (i.e., hyponatremia) which could eventually lead to seizure, coma, and death. To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed.”
Read the Ferring US recall announcement.
