NAFDAC Alerts The Public On The Extreme-Capacity Of DDAVP, Demopressin And Stimate Nasal Sprays

The National Agency for Food and Drug Administration and Control has been informed by the US Food and Drug Administration that a pharmaceutical company based in the US, “Ferring Pharmaceuticals” is voluntarily recalling all lots of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL to the consumer level.

According to NAFDAC these products are being withdrawn due to its extreme capacity and higher amounts of desmopressin than specified which was discovered during timely testing.

NAFDAC explained that larger quantity of desmopressin, than specified may cause abnormally low levels of sodium in the blood, that is hyponatremia, which could eventually lead to seizure, coma, and death.

NAFDAC noted that the nasal spray an antidiuretic replacement therapy used in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia in cases of head trauma.

NAFDAC further stated that Stimate® Nasal Spray is used for the treatment of patients with haemophilia A with Factor VIII coagulant activity levels greater than 5% and for treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

The National Agency for Food and Drug Administration and Control has therefore charged healthcare providers to desist from prescribing or distributing the above products and should remove them from the shelves within your store.

NAFDAC however urged the healthcare providers to return unused products to the NAFDAC office closest to them for regulatory action. NAFDAC therefore implored all importers, wholesalers, and retailers to immediately stop the importation, distribution, and use of the recalled products.