Recall on Ferring’s Intranasal Desmopressin Therapies to Affect Availability Into 2021
A recall on Ferring Pharmaceuticals‘ intranasal desmopressin compounds — used to treat mild to moderate hemophilia A and von Willebrand disease type 1 — is expected to affect the availability of these products until at least mid- to late-2021, according to an advisory from the World Federation of Hemophilia.
Ferring initiated the worldwide recall over the summer, citing higher-than-specified concentrations of desmopressin — a synthetic analogue of vasopressin — in several formulations. The company and other agencies around the world made recall announcements from July 10 to Aug. 5.
Too much desmopressin can cause sodium levels in the blood to drop enough to result in seizures, coma, and death.
The recall extends to 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. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada.
Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken.
During the interruption, therapeutic alternatives include clotting factor concentrates, Cyklokapron (tranexamic acid), and other forms of desmopressin, such as subcutaneous (under-the-skin) or intravenous (into-the-vein) injections.
Patients and caregivers may need training on how to administer injections and should coordinate care with their healthcare providers, particularly in how to manage severe bleeding events and surgery-related care.
Stimate Nasal Spray boosts levels of blood clotting factor VIII and von Willebrand factor.
Most countries only require retailers to return the affected lots. However, patients may want to consult their providers and consider returning any unused product to pharmacies, according to the World Federation of Hemophilia.
Ferring has not reported seeing an increase in adverse events due to the increased desmopressin levels. One non-fatal event potentially associated with this issue occurred in the U.S., within the timeframe that the recalled lots were distributed.
In addition to blood-clotting disorders, desmopressin works as an anti-diuretic — to decrease urination — and is used to treat central diabetes insipidus, wherein the body doesn’t make the hormone vasopressin. DDAVP Nasal Spray and Desmopressin Acetate Nasal Spray are used for this indication, and in managing head trauma or surgery in the pituitary region.
A complete list of affected lots is included in the recall announcement made by the U.S. Food and Drug Administration.