The regulations describe a boxed warning as a way to highlight certain contraindications or serious warnings, particularly those that may lead to death or serious injury. In prescribing information in the Physician Labeling Rule format (21 CFR 201.57), it appears in the Highlights and again in the full text, with a heading that starts with "WARNING:" followed by the subject. FDA can require one for an approved drug, and changes to a boxed warning are among the most closely scrutinized labeling changes. See also prescribing information and Medication Guide.
Why it matters for labeling
The boxed warning has to read identically everywhere the labeling is reproduced: the prescribing information, the SPL file, and any material built from them. Its formatting is part of its meaning, so the box and the bold type can't be lost when text moves between formats. Promotional materials that make claims about the drug have to present risk information with appropriate prominence, so a boxed warning can't be buried or trimmed in a derivative piece.
Common mistakes
- Warning text that differs between the Highlights, the full text and the SPL file
- The box or bold formatting lost when converting between formats
- An outdated warning left in place after a safety labeling change
- The warning shortened or left out of a derivative piece