11 August 2020
EHC Statement on Desmopressin Nasal Sprays availability
The European Haemophilia Consortium (EHC) has become aware of an international recall of all Ferring Pharmaceuticals Limited nasal sprays containing desmopressin, including Octim®, Octostim®, Desmospray®, DDAVP Spray® and Stimate®. This may lead to shortages over the course of 2020.
About Desmopressin nasal sprays
Desmopressin acetate is the active ingredient in the nasal sprays manufactured by Ferring Pharmaceuticals Limited. This spray is typically used in people with Von Willebrand Disease types 1 and 2 (except 2B) and mild haemophilia. It is also used for women with heavy menstrual bleeding.
About the recall of Desmopressin nasal sprays
On 15th July 2020, Ferring Pharmaceuticals Limited recalled all unexpired stock of all strengths of desmopressin nasal spray from pharmacies and wholesalers worldwide. The decision was made due to efficacy issues. The vials of these nasal sprays were found to contain a lower volume of solution and hence out of specification for the content of the desmopressin acetate (active substance) and benzalkonium chloride (excipient). This was found to lead to an “out-of-specification result concerning the desmopressin content (155% of the targeted amount),” meaning that there was more of the active ingredient, desmopressin, within each vial – which could “cause adverse health consequences due to increased concentrations of desmopressin.” The precise cause of this defect remains to be determined.
Ferring Pharmaceuticals Limited has announced that the product will remain unavailable until 2021.
Advice to patients
It is advised to patients who use this product to seek advice from your haematologist, gynaecologist or other healthcare professional with regard to suitable alternatives to desmopressin nasal spray such as intravenous or subcutaneous formulations of desmopressin.
The EHC will continue to monitor the situation as well as follow-up closely regarding future product availability and safety, and will and provide further information as the situation evolves.
Further information from governmental sources and partner patient organisations:
- Alert from the UK Government,
- Alert from the Government of Canada in English and French,
- Announcement from the Austrian Federal Office for Safety in Health Care (BASG) in English and German,
- Announcement from the National Hemophilia Foundation (NHF – USA),
- Notice from the World Federation of Hemophilia (WFH).