An internal investigation conducted by Ferring Pharmaceuticals into its recently recalled desmopressin nasal spray formulations found an issue with the tightness of the bottle seal. Measures taken to prevent recurrence of the issue will affect the availability of the products through at least 2023.
The company announced in a press release its plans to install a new production line to prevent the bottle seal issue from occurring again, with the production of its desmopressin products expected to resume in the first half of 2023. Market availability is expected by the end of that year, pending approval from respective health authorities.
The precautionary global recall of the desmopressin formulations used to treat mild-to-moderate hemophilia A and von Willebrand disease was initiated by the company in July and August after higher-than-specified concentrations of desmopressin were found in several formulations. In an advisory last fall, the World Federation of Hemophilia said the recall likely would affect availability through at least mid-year, possibly later.
Desmopressin — a synthetic analogue of the hormone vasopressin — functions by boosting levels of factor VIII, deficient in hemophilia A, and von Willebrand factor, which is found at low levels or in a non-functional form in von Willebrand disease. Both of these clotting factors are critical to the biological pathway that culminates in the formation of a blood clot.
Among the recalled products is Stimate, a nasal spray containing a synthetic form of desmopressin acetate that is used to control bleeding in patients with hemophilia.
In addition to Stimate, the announcement extends to Octostim Nasal Spray 1.5 mg/ml, DDAVP 10 micrograms (mcg)/0.1 ml, Minirin Nasal Spray 0.1 mg/ml, and Generic Desmopressin Acetate Nasal Spray 10 mcg/0.1 ml.
Ferring will continue manufacturing Minirin Nasal Spray 0.1 mg/ml, oral desmopressin, and injectable desmopressin (4 mcg/ml and 15 mcg/ml). Patients should consult their healthcare providers about an appropriate therapeutic alternative, including other formulations of desmopressin and Cyklokapron (tranexamic acid).
The products containing higher-than-specified concentrations of desmopressin were recalled due to concerns that increased exposure to desmopressin can cause water retention, low blood pressure and low blood sodium levels in mild cases, and seizure, coma, and death in extreme cases.
To date, no adverse side effects related to the recalled products have been reported, Ferring stated.