The reason for the confusion is muddled in a myriad of labeling regulations for both prescription and over-the-counter (OTC) medications. ![]() It is easy to see how pharmacy staff and other clinicians might be misled and incorrectly assume that all color additives are listed on the principal display panel since the FD&C yellow #6 is listed there. The principal display panel on a large bottle of ibuprofen oral suspension from Perrigo indicates that it “Contains FD&C yellow #6,” but the product also contains D&C red #33, which is only listed in the package insert. Fortunately, a pharmacy staff member read the package insert and noticed that the product also contained D&C red #33 before the product was dispensed for the child. However, another color additive, FD&C yellow #6, was listed there ( Figure 1), leading the pharmacy technician and pharmacist to initially and incorrectly assume that this was the only color additive in the product. Pharmacy staff discovered that the package insert for a prescription-only 473 mL bottle of ibuprofen oral suspension (100 mg/5 mL) from Perrigo specified that the product contained D&C red #33, but this inactive ingredient was not listed on the bottle’s principal display panel. Ibuprofen oral suspension was prescribed for a 7-year-old child with a known red dye allergy. 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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