Hemophilia Federation of America is a national nonprofit organization that assists, educates and advocates for the bleeding disorders community.
Bayer announced the recall of two lots of Kogenate庐聽FS antihemophilic factor (recombinant) 2000 I.U. vials on July 19, 2019. Bayer announced that 3000 I.U. of one product (Jivi), past its expiration date, had been mislabeled as another product (2000 I.U. of Kogenate FS) and distributed to the public for six months. This is a deeply […]
The following is a press release from Bayer regarding a voluntary recall. PATIENTS SHOULD NOT USE THIS PRODUCT! Bayer is voluntarily recalling two lots of Kogenate庐 FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain […]
Note: The following is the full text of an email communication received by HFA from Bayer HealthCare Pharmaceuticals: Bayer in consultation with the FDA has voluntarily recalled approximately 300 vials (part of one lot) of Kogenate庐 FS, Antihemophilic Factor (Recombinant) in the U.S. as聽an excipient, used to stabilize the product during manufacturing, may not conform […]
It has come to our attention that Helixate FS, a recombinant clotting factor product sold and distributed by CSL Behring, is being removed from prescription benefit programs for a limited number of聽patients using CVS/Caremark effective January 1, 2017. Patients currently using Helixate FS who have the “Advanced Control Formulary” plan with聽CVS/Caremark will have the […]
Bayer has announced a voluntary recall of additional聽lots of Kogenate聽FS with vial adapter. This is an update to the recall that was issued on July 25, 2016.聽All lot numbers affected by the July 25, 2016 recall and August 10, 2016 extension are: Product Lot Number Expiration Date Kogenate FS 250 IU Vial Adapter 270RV8X 12/19/2017 […]
As part of HFA鈥檚 ongoing mission to assist and advocate for the bleeding disorders community, this medical news is being issued to keep you informed about product safety. About These Withdrawals CSL Behring is initiating a voluntarily recall of two lots of its hemophilia A drug Helixate FS containing active ingredient manufactured before November 2015. […]
On September 24, 2014, the medical journal,聽Blood, came out with a study called,聽Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.聽 This study suggests聽that inhibitor incidence is higher in previously untreated patients (PUPs) with severe hemophilia A that are using聽Kogenate/Helixate.聽 The聽World Hemophilia Federation聽(WHF) issued a聽statement on October 6,聽and another […]
On September 24, 2014, the medical journal,聽Blood, came out with a study called,聽Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.聽 This study suggests聽that inhibitor incidence is higher in previously untreated patients (PUPs) with severe hemophilia A that are using聽Kogenate/Helixate. The Food and Drug Administration聽(FDA)聽and European Medicines Agency (EMA)聽have […]
On September 24, 2014, the medical journal, Blood, came out with a study called, Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.聽 This study suggests聽that inhibitor incidence is higher in previously untreated patients (PUPs) with severe Hemophilia A that are using Kogenate/Helixate (Bayer/Nexgen). Click here to read the […]
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