FD&C Yellow No. 5 Lake
Excipient (pharmacologically inactive substance)
What is it?
FD&C Yellow No. 5 is approved as a food-coloring additive in the U.S. FDA performs regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. FD&C Yellow No. 5 is a FDA-approved color commonly used to dye dosage forms such as tablets, capsules, vitamins and antacids. Commonly known as tartrazine, Yellow No. 5 is an azo dye that imparts a lemon-yellow color to foods, drugs and cosmetics.
FD&C colors are the colors certified for use by the U.S. FDA in the food, drug, and cosmetic industry. The FDA states that FD&C Yellow No. 5 may be safely used as a color additive when their specifications are followed.
Over-the-counter and prescription drugs that contain tartrazine shall bear statements on the label stating that the product contains FD&C Yellow No. 5 (tartrazine) as a color additive or contains color additives including FD&C Yellow No. 5 (tartrazine). They may also state that FD&C Yellow No. 5 (tartrazine) may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. This warning statement shall appear in the "Precautions" section of the labeling.
The use of tartrazine in susceptible patients has been reported to lead to allergic or adverse reactions, such as urticaria (hives), eczema, angioedema, asthma and hyperactive behavior. Studies also suggest that patients with asthma and aspirin allergies may have a higher incidence of allergies to azo dyes such as tartrazine. Often, the drugs used to treat severe allergic reactions to tartrazine, such as some antihistamines and corticosteroids, may contain tartrazine, worsening symptoms even further. However, other well-controlled reviews and randomized, controlled trials have not found a higher risk for tartrazine use in patients with asthma and aspirin sensitivity. Patients with a known allergy to tartrazine should discuss with their physician whether they should avoid the additive in food, drugs and cosmetics. Organic foods often use the natural dyes annatto or beta carotene to color food yellow, and might a suitable alternative.
Lakes are formed by reacting straight dyes (such as FD&C Yellow No. 5) with precipitants and salts. Aluminum may be a component. Lakes may be used as color additives for tablet coatings due to their stability.
 Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Listing of color additives subject to certification. Subpart B. Drugs. Accessed online October 19, 2011. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=c387334e82029536a53dde1171ba5481;rgn=div5;view=text;node=21%3A184.108.40.206.27;idno=21;cc=ecfr#21:220.127.116.11.18.104.22.168
 U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed 10/20/2011. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm