PharmacovigilanceOfficial

FDA CBER lists 2026 safety notices, from Adzynma boxed warning to immune globulin withdrawals

🇺🇸 FDA CBER · Fri 23 Oct 2026

The agency's updated 2026 index covers Ebola donor guidance, immune globulin lot withdrawals, a new Adzynma boxed warning, BabyBIG dosing changes and flu vaccine labelling letters.

FDA's Center for Biologics Evaluation and Research has updated its page of 2026 Safety and Availability Communications, current as of 23 October 2026. The page links to notices but the text provided gives only titles and dates, not the content of each communication.

The latest entries are from October. On 23 October CBER posted a notice headed "Important Changes in BabyBIG® Lot 8 Dosage and Administration Information". On 22 October it updated its information for blood establishments on Ebola disease and blood donation. On 7 October it listed voluntary lot withdrawals of intravenous (IGIV) and subcutaneous (IGSC) immune globulin because of increased reports of allergic or hypersensitivity reactions.

Adzynma, the enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP), appears twice. A 23 September entry says FDA took action on a new boxed warning for the product. A 20 May entry lists a safety labeling change order and an accompanying notification letter. Safety labeling change notices generally set out new safety information that FDA wants reflected in a product's labelling.

Other entries include a July notice for HCT/P establishments on Ebola disease and donation, and a June notice for blood establishments on the same subject. The expiry of North American Coral Snake Antivenin (Micrurus fulvius) lot CL6814 was extended through 30 June 2026 and later through 31 December 2026. The page also carries a patient and consumer warning on the risks of unapproved products made from human cells or tissues. On 9 January CBER issued safety labeling notification letters for six influenza vaccines: Fluzone, Flumist, Fluarix, Flulaval, Afluria and Flucelvax.

What it means for your team

  • Companies and clinical sites handling immune globulin, BabyBIG or Adzynma should read the full CBER notices, as the index gives no detail on the actions required.
  • Blood and HCT/P establishments should check the Ebola-related updates against their donor screening and deferral procedures.
  • Flu vaccine marketing authorisation holders and regulatory teams should confirm that labelling responses to the January safety labeling notification letters are tracked and complete.
  • Supply and quality teams holding coral snake antivenin lot CL6814 should note the expiry extension through 31 December 2026.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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