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Even the most beneficial medical treatments are never entirely without risk, but uncommon adverse events often are not identified before treatments are deployed widely in unselected populations. How often have modern vaccines caused substantial problems after U.S. FDA approval? Israeli researchers analyzed postapproval safety-related label changes for 57 vaccines that were approved by the FDA between 1996 and 2015. Almost 40% of these products were directed against seasonal influenza. More than 90% had been validated by premarketing randomized controlled trials.
Overall, 25 of the 57 products generated 58 postmarketing safety-related label modifications (49 warnings, 8 contraindications, 1 removal). Median time to label change was 5 years af…