Stimate Recall: NHF and HFA Seek Answers
Immediately following the issuance of medical advisories to the community regarding the recall of Stimate® (desmopressin nasal spray ) a product used to control bleeding in patients with von Willebrand disease and hemophilia A, the National Hemophilia Foundation and Hemophilia Federation of America sent a joint letter to CSL Behring, which sells and distributes Stimate® in the US and Ferring Pharmaceuticals, which owns and manufactures the product.
On July 21st, Ferring Pharmaceuticals issued a voluntary recall of Stimate®. The issue that sparked the recall was an “out-of-specification result concerning the desmopressin content (155% of the targeted amount),” meaning that there was more of the active ingredient desmospressin within each vial – which could “cause adverse health consequences due to increased concentrations of desmopressin.”
The joint letter to Ferring and CSL Behring seek more information on this issue, including: the fact that affected lots appear to have been distributed as early as December, 2017; that recall notices were issued in Europe and South America ten days before being issued in the US; questions regarding the discovery of the issue, and what steps are being taken to ensure future product safety.
NHF and HFA expect a prompt response from CSL and Ferring and will share the response with the bleeding disorders community when it is received. Further, they expect the communications with Ferring and CSL Behring to continue until they have a complete understanding of the potential impact on the bleeding disorders community and how the future safety of Stimate® will be secured. NHF and HFA will continue to keep the bleeding disorders community informed as these communications continue.