Three Types Of Nasal Sprays Recalled Over High Levels Of Desmopressin

Ferring Pharmaceuticals US has recalled three nasal sprays as they contain excessive amounts of a man-made hormone used to treat conditions like diabetes.

The Food and Drug Administration (FDA) issued a notice Wednesday, Aug. 5, about the voluntary recall of three types of nasal sprays by Ferring Pharmaceuticals US because they contain excessive amounts of a synthetic hormone used in treating health issues that include frequent urination and a type of diabetes. The drug company was pulling the sprays out of the market because the amounts of desmopressin in them were higher than what is specified, FDA said.

Ferring US also sent letters to its wholesale customers and distributors regarding the recall, CBS News reported. It asked customers to check for the affected product and to return unused nasal sprays.

The FDA also warned about the risks associated with too much of desmopressin, which include unusually low levels of sodium in the blood that may lead to seizure, coma and death. Scientists discovered the issue during a routine analysis, with one non-fatal "adverse event" likely associated with the problem reported in the United States.

The recalled nasal sprays are Stimate Nasal Spray 1.5 mg/mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL and DDAVP Nasal Spray 10 mcg/0.1mL. Doctors prescribe Stimate nasal spray for patients suffering from mild to moderate classic von Willebrand's disease, a blood-clotting ailment, or those with hemophilia A.

Patients use Desmopressin Acetate and DDAVP nasal sprays as antidiuretic replacement treatments in managing central cranial diabetes insipidus, as well as temporary polyuria or excessive urination and polydipsia or excessive drinking due to thirst, after sustaining head trauma or having surgery in the pituitary region.

The FDA also included the batch numbers and expiration dates of the recalled nasal sprays in its notice. Patients experiencing adverse reactions after using any of these nasal sprays were requested to report to the MedWatch Adverse Event Reporting program.