Update on the Ferring recall of desmopressin products

Publicado en: Hemofilia y Otras Coagulopatías
Tags:

El suministro de los sprays nasales de desmopresina no se reestablecerá, previsiblemente, hasta la segunda mitad del 2023.

Update on the Recall of Desmopressin Nasal Sprays

The European Haemophilia Consortium (EHC) would like to provide an update on its November 2020 statement on the international recall of all Ferring Pharmaceutical Limited nasal sprays containing desmopressin, including Octim®, Octostim®, Desmospray®, DDAVP Spray® and Stimate®.

In February 2021, Ferring informed both the World Federation of Hemophilia (WFH) and the EHC that it had completed its internal investigation into the causes of its higher than the specified concentration of desmopressin. This was the result of an issue in the tightness of the seal of the bottle.

The company further indicated that to prevent this issue recurrence, it intended to procure, install and qualify a new production line.

Based on the timelines needed to complete these tasks, the company anticipates that it will restart manufacturing the following products in Q2 of 2023, with first deliveries to the market anticipated in the second half of 2023 (depending on the respective health authority approval). This concerns the following products:

  • Minirin® (desmopressin) Nasal Spray 0.1 mg/ml room temperature stable (RTS) formulation
  • Octostim® (desmopressin) Nasal Spray 1.5 mg/ml
  • DDAVP® (desmopressin acetate, 10 mcg/0.1 mL)
  • Stimate® (desmopressin acetate, 1.5 mg/1 mL) Nasal Spray
  • Generic Desmopressin Acetate (10 mcg/0.1mL) Nasal Spray

Ferring continues to manufacture the following desmopressin products, whose availability varies by market:

  • Minirin® (desmopressin) Nasal Spray 0.1 mg/ml Cold Storage Formulation
  • Desmopressin Oral (tablet and oral lyophilizate) formulations
  • Desmopressin Injectable formulations

In addition, other dosage forms of desmopressin acetate are available from other manufacturers.

Healthcare providers can contact their pharmacies and/or the manufacturers of these dosage forms for information about these alternatives’ availability.

Background

  • 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 haemophilia 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 haemophilia 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 were 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 the unused product to the pharmacy after consulting their treatment centres
  • Ferring completed its internal investigation and identified the cause of the issue in relation to the tightness of bottle seals
  • Ferring announced a complete overhaul of its production line with planned resuming of manufacturing of desmopressin products to Q2/2023 and supply to the market in the second half of 2023, at the earliest

Risks 

  • Potential health consequences of exposure to an increased amount of desmopressin include water retention, hypotension, and hyponatremia (low sodium concentration in the blood),1which in some extreme cases could lead to a 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

  • Ferring announced a complete overhaul of its production line with planned resuming of manufacturing of desmopressin products to Q2/2023 and supply to the market in the second half of 2023, at the earliest
  • Pending manufacture restart, 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 the management of bleeding events and perioperative care
  • In collaboration with healthcare providers and national authorities, NMOs are advised to update their communities on the situation in their countries
  • Healthcare providers are asked to look into alternative products with their local pharmacists to ensure patients continue to access desmopressin-based treatments

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-acetateAccessed August 5, 2020.

Change this in Theme Options
Change this in Theme Options
Ir a la barra de herramientas