Abstract
Background: Medical dyes are used in the hospital setting for various diagnostic, procedural, and treatment indications. In some cases, they are used for indications that are not approved by the Food and Drug Administration (FDA). Objective: This study aimed to assess the real-world utilization of the following commonly used dyes: methylene blue, indigotindisulfonate sodium, fluorescein, isosulfan blue, and indocyanine green. Methods: This was a single-center, retrospective study including adults who were administered methylene blue, indigotindisulfonate sodium, fluorescein, isosulfan blue, or indocyanine green between March 2023 and August 2023 at a tertiary academic medical center. No exclusion criteria were applied. The primary outcome was the percentage of dye administrations with an FDA-approved indication, both total and stratified by each dye. The indication for each administration was identified via chart review using procedure and progress notes. Results: A total of 616 administrations were analyzed. Of these administrations, 19 (3.1%) had an FDA-approved indication, whereas 597 (96.9%) did not. Methylene blue and indocyanine green were the most commonly used dyes outside of their FDA-approved indication. A total of 351 methylene blue administrations (57.0%) and 233 indocyanine green administrations (37.8%) were off-label. Conclusion: In the hospital setting, medical dyes may be used for various indications, some of which may not be FDA approved. Establishing institutional policies and procedures surrounding the use of dyes may help guide their use in the hospital setting.