A manufacturing deviation at NovoNordisk's Danish facility has led to the potential underfilling of vials for NovoSeven©, crucial treatments for hemophilia and other blood disorders. While alternative treatments exist, the NovoSeven shortage could have significant implications due to its unique indications and limited alternatives.
The European Haemophilia Consortium (EHC), National Bleeding Disorders Foundation (NBDF), and World Federation of Hemophilia (WFH) are closely monitoring the situation. Although no immediate supply issues have arisen, the full impact may become apparent by late 2024.
Patients currently using these treatments are advised to consult their healthcare providers.
Read the full article for detailed information on affected products, potential alternatives, and ongoing efforts to address this critical issue in hemophilia care.
July 2, 2024
On Friday, June 28th, Novo Nordisk sent a letter to NBDF sharing more information about the current product issue related to NovoSeven® RT and Novoeight ®. The letter is in response to questions that NBDF asked Novo to better understand the cause of this product issue, the potential impact on patients in the United States, and how Novo plans to address it. NBDF appreciates this additional information, and we will continue to work together with our global partners to raise additional questions and concerns as needed.
NBDF has pledged to update the community regularly as more information becomes available and will continue to do so as this situation evolves. We appreciate Novo Nordisk’s responsiveness to this issue and their commitment to our community.
Please contact your HTC if you have concerns about your treatment regimen and availability. You can also contact Novo Care customer support at 1-844-668-6732.
June 14, 2024
NBDF has learned about a product issue with NovoSeven® RT and Novoeight®. This is not a product recall, instead there is a concern about the manufacturing process. This manufacturing issue has led to a temporary shortage of the NovoSeven® RT 1 mg and 2 mg vials and some strengths of Novoeight® at the Novo Nordisk Distribution Center (NNDC).
We have not yet received more information about affected lot numbers. NBDF and our global partners are seeking additional information about lot numbers, where the product has been distributed, and how Novo has communicated with the community and providers. We will be officially sharing our concerns with Novo and will share their response publicly.
Please reach out to your HTC if you have concerns about your treatment regimen and availability. If you would like to contact Novo directly, please call the Novo product inquiry line at 1-800-727-6500.
This is only the first step in what we expect to be continuing communications with Novo and the FDA about this event.
