Update to WFH Notice: Global recall of Octim®/Octostim® desmopressin nasal spray (1.5 mg/ml) by Ferring Pharmaceuticals
With ongoing investigation following the mid-July global recall of intranasal desmopressin products by Ferring Pharmaceuticals, disruption and unavailability of supply is expected to continue until at least mid- to late 2021. The following is a summary and update from the WFH Coagulation Product Safety, Supply, and Access Committee on the availability of alternative therapeutic options.
- Desmopressin (1-deamino-8-D-arginine vasopressin, also known as DDAVP) is a synthetic analogue of vasopressin that boosts plasma levels of factor VIII and von Willebrand factor1
- Desmopressin may be the treatment of choice for patients with mild or moderate hemophilia A, including carriers, and many patients with von Willebrand disease (VWD), particularly those with type 1 VWD1
- Though desmopressin may be given subcutaneously, it is primarily administered by intravenous infusion or nasal spray1
- Ferring Pharmaceuticals initiated a worldwide precautionary recall of its desmopressin nasal sprays in mid-July 2020, including the formulation used in the treatment of mild/moderate hemophilia and VWD (Octostim®, Octim®, Stimate® by CSL Behring, and other brand names worldwide)
- The withdrawn formulations contained higher than specified concentrations of desmopressin
- Recall announcements were issued around the world from July 10 to August 5 by different parties: Ferring Pharmaceuticals, national regulatory authorities, ministries of health, and distributors
- The recall level (i.e., pharmacy or patient level) and formulations withdrawn at the national level vary according to local regulatory decisions and requirements
- Although the majority of countries have issued pharmacy-level recalls, patients may consider returning unused product to the pharmacy after consulting their treatment centres
- Potential health consequences of exposure to an increased amount of desmopressin include water retention, hypotension, and hyponatremia (low sodium concentration in the blood),1 which in some extreme cases could lead to seizure, coma, and death2
- No reports of adverse events that have been linked to the use of out-of-specification batches are known at this time
Availability of alternative options
- Investigation of the causes of the defective formulations is still ongoing
- It is unknown at this time when the manufacture of intranasal desmopressin formulations will resume. Given that the investigation is still ongoing and corrective measures and actions may take a while, manufacturing will not re-start anytime soon and these products will likely be unavailable until at least mid- to late 2021.
- Pending manufacture re-start, injectable (intravenous or subcutaneous) formulations of desmopressin (4 micrograms/mL and 15 micrograms/mL) are available and should be considered as alternative options for affected patients
- Patient/caregiver education and training on administration of subcutaneous or intravenous treatment is recommended as needed
- Coordination with healthcare providers is recommended for all patients affected by the recall to discuss alternative therapeutic options (e.g., clotting factor concentrates, tranexamic acid, or alternative forms of desmopressin) that may be needed, particularly for management of bleeding events and peri-operative care
- In collaboration with healthcare providers and national authorities, NMOs are advised to update their communities on the situation in their countries
1 Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020:26(Suppl 6):1-158. http://doi.org/10.1111/hae.14046
2U.S. Food and Drug Administration. Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency. FDA website. Silver Spring, MD: U.S. Food and Drug Administration. http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate Accessed August 5, 2020.