ADR that result in revision of patient information - 2021-03-25 (1)
FDA mandates a Guillain-Barré Syndrome (GBS) warning for Shingrix, following postmarketing studies showing an increased GBS risk within 42 days post-vaccination. Evidence suggests an association, not causation, with 3-6 excess GBS cases per million doses in adults over 65. Benefits of Shingrix still outweigh risks.
Reference News
ADR that result in revision of patient information - 2021-03-25 (1)
FDA mandates a Guillain-Barré Syndrome (GBS) warning for Shingrix, following postmarketing studies showing an increased GBS risk within 42 days post-vaccination. Evidence suggests an association, not causation, with 3-6 excess GBS cases per million doses in adults over 65. Benefits of Shingrix still outweigh risks.