![]() ![]() While the product’s principal display panel on the immediate container clearly listed FD&C yellow #6, the D&C red #33 color additive was only listed in the package insert. ISMP recently received a report about a medication that contained D&C red #33 that, due to labeling confusion, was almost dispensed for a patient with a red dye allergy. Patients who are allergic to these approved color additives and unknowingly take or apply medications that contain them may experience hypersensitivity reactions that range from mild (e.g., stomach cramps, skin reactions, and rashes), to moderate (e.g., facial swelling, hives, skin lesions, wheezing), to severe (e.g., anaphylactic reactions). These approved colorants can be found in many medications. Yellow dyes, particularly FD&C yellow #5 (tartrazine) and FD&C yellow #6 (Sunset Yellow)īlue dyes, particularly FD&C blue #1 (Brilliant Blue)įD&C (short for Federal Food, Drug, and Cosmetic Act) in front of the colorant name and number (e.g., FD&C yellow #6) indicates that it has been approved for use in food, drugs, and cosmetics, and D&C (e.g., D&C red #33) indicates it has been approved for use in drugs and cosmetics. Red dyes, particularly FD&C red #4 (carmine, only approved for use in externally applied drugs) and FD&C red #40 (Allura Red) Even though allergies to these approved color additives are relatively infrequent, a few in particular have been linked to intolerances and allergic reactions: Problem: Some patients are sensitive to the color additives approved by the US Food and Drug Administration (FDA) for use in medications.
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