The company is planning to conduct a postmarketing study of Alphanate
in patients with type 3 vWD who are undergoing major surgery.
Currently licensed for treatment of hemophilia A, Alphanate
gained approval for treatment of von Willebrand disease in the United Kingdom in 2001 and in Italy in 2002.
Medicines may be prescribed to increase the release of von Willebrand factor into the bloodstream (desmopressin, administered either intravenously or through a nasal spray like Stimate(R)), replace von Willebrand factor (Humate-P(R) or Alphanate
SD-HT(R)), prevent the breakdown of clots (antifibrinolytics) or to control heavy menstrual bleeding in women (oral contraceptives).
The recall affects only those products filled in one particular area between December 11, 1997 and June 25, 1998 under the trade names: Alphanate
Antihemophilic Factor (Human); AlphaNine SD Coagulation Factor IX (Human); Albutein Albumin (Human) - 20 ml size only; Profilate SD Antihemophilic Factor (Human); Profilnine SD Factor IX Complex; and Venoglobulin-S Immune Globulin Intravenous (Human).