FDA Drug Safety Communications are public regulatory communications used to describe important new or evolving safety information about medicines.
Official resource
Practical use
Use this repository to track FDA safety actions that may affect labelling, contraindications, warnings, monitoring recommendations, prescribing practice or ongoing benefit-risk evaluation. Communications should be cross-checked against the current U.S. Prescribing Information and, where relevant, associated FDA approval history or safety-labelling changes.
Because communications may be updated as evidence develops, the current FDA page should be treated as the authoritative version rather than relying on an archived internal copy.