Summaries of Safety Labeling Changes Approved By FDA: Boxed WarningsHighlights April-June 2018

摘要

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiledquarterly for drugs and therapeutic biologics where important changes have been made tothe safety information. These and other label changes are searchable in the Drug SafetyLabeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats.Boxed warnings are ordinarily used to highlight adverse reactions so serious inproportion to the potential benefit from the drug that it is essential that it beconsidered in assessing the risks and benefits of using the drug; OR serious adversereactions that can be prevented/reduced in frequency or severity by appropriate use ofthe drug; OR FDA approved the drug with restrictions to ensure safe use because FDAconcluded that the drug can be safely used only if distribution or use isrestricted.