FDA

FDA requires Guillain-Barré syndrome warning for RSV vaccines

January 8, 2025

FDA has required and approved safety labeling changes to the prescribing information for Abrysvo and Arexvy. Specifically, the agency is requiring that each manufacturer include a new warning about the risk for Guillain-Barré syndrome following administration of their respective RSV vaccines.

The prescribing information for each vaccine has been revised to include the following language in the Warnings and Precautions section:

• Abrysvo - The results of a postmarketing observational study suggest an increased risk of GBS during the 42 days following vaccination with Abrysvo.
• Arexvy - The results of a postmarketing observational study suggest an increased risk of GBS during the 42 days following vaccination with Arexvy.

Suspected adverse events should be reported to VAERS, which is co-managed by FDA and CDC.

Source:

FDA. (2025, January 7). FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication. https://www.fda.gov/safety/medical-product-safety-information/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and