New Serious Safety Warnings for Targeted Anticancer Agents After Their Initial FDA Approval.

ABSTRACT: Background: New safety concerns about targeted anticancer agents (TAAs) often emerge in the first few years after their initial regulatory approval. Our aim was to determine whether new serious and potentially fatal adverse drug reactions (ADRs) continue to emerge in the updated drug labels of TAAs several years after their initial regulatory approval and whether their emergence can be predicted. Methods: The updated drug labels of TAAs approved by the U.S. Food and Drug Administration before July 2013 were analyzed. Serious and potentially fatal ADRs were identified in the Warnings & Precautions (WPs) and Boxed Warnings (BWs) sections of the updated drug labels. Generalized linear mixed models were used to examine the associations between the number of adverse drug reactions

SUBMITTER: Stefanovski D 

PROVIDER: S-EPMC11853166 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature