Bayer Recalls Mislabeled Kogenate FS

Hemophilia Non-Profit Groups Seek Answers from Bayer on Recent Recall of Mislabeled Gene Replacement Therapy Drug

Bayer recall

UNITED STATES – According to an online news article published by hemophilianewstoday.com, the National Hemophilia Foundation (NHF) and Hemophilia Federation of America (HFA) are seeking clarification from Bayer regarding the recent recall of mislabeled Kogenate FS, a gene replacement therapy for hemophilia A.

Bayer manufactures two factor VIII replacement therapies for hemophilia A – Kogenate FS and Jivi.  Bayer recently issued a recall of 986 mislabeled Kogenate FS vials that contained Jivi instead of Kogenate FS.  Both therapies deliver the clotting factor VIII, which is missing in people with hemophilia A.

The gene replacement therapies are used both prophylactically and for on-demand treatment. However, the formulation of Kogenate FS and Jivi are not the same.  Kogenate FS is approved to treat children and adults, while Jivi is approved for use in previously treated adults and adolescents age 12 and older with hemophilia A.

Because of the importance of the difference in formulation between Kogenate FS and Jivi, the NHF and HFA have sought clarification from Bayer to determine whether any mislabeled Kogenate FS had been distributed to any children under the age of 12.  Bayer’s statement in response to the NHF and HFA is that the company has “no information that any patient under the age of 12 received the recalled product.”

Also, the NHF and HFA raised concerns about Bayer’s delay in issuing a recall.  Reports indicate that Bayer’s recall of Kogenate FS came 4 days after the last distribution date of the mislabeled drug. Bayer asserts that it followed all regulatory requirements in issuing a recall of the mislabeled Kogenate FS vials.

Bayer has reached out to distributors and healthcare providers with instructions on how to address the recalled vials of Kogenate FS.  So far, there have been no reports of injuries or adverse events associated with the mislabeled drug.  However, Bayer is “conducting a review of all adverse events described in news reports,” and all information obtained with be shared with the FDA.