Boxed warnings, also commonly called “black box warnings”, are the FDA’s most prominent warning. They are required on labeling of certain drugs to advise of serious adverse effects, dangerous drug interactions, risks of abuse/misuse, addiction, and other priority concerns. The FDA’s guidelines indicate that boxed warnings are ordinarily indicated when:
- A potential adverse reaction is so serious in proportion to the drug’s foreseeable benefit that it should be considered if benefits outweigh potential benefits.
- A serious adverse reaction can be prevented or mitigated by appropriate use of the drug, such as regulated frequency, cautious patient selection, therapeutic monitoring, avoiding combination with other drugs, etc.
- The FDA only approved the drug with stipulation of certain risk mitigation strategies.