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FDA Warns of Hypersensitivity Reactions with Over-the-Counter Acne Products

Sep 15, 2014

The Food and Drug Administration (FDA) has warned that over-the-counter (OTC) topical acne products containing benzoyl peroxide and salicylic acid can cause rare but serious allergic reactions or irritations.

The FDA cites “products of concern” in the warning, including such brands as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. The products are available in a number of forms: gels, lotions, face washes, cleansing pads, toners and face scrubs.

In the warning, the FDA said benzoyl peroxide and salicylic acid could cause hypersensitivity reactions including swelling of the eyes, face, lips, or tongue, throat tightness, difficulty breathing, feeling faint, and hives or itching where the topical treatment was used. Consumers should stop using the product if they develop hives or itching and should not use any of these products again if they have experienced a hypersensitivity reaction.

From 1969 through early 2013, the FDA received 131 reports of allergic and hypersensitivity-related adverse reactions associated with these OTC acne products.  Though no deaths were reported, 44 percent of the cases required hospitalization. Serious hypersensitivity reactions differ from the local skin irritations that may occur at the product application site and that are already included in the Drug Facts labels. Dr. Doris Day, clinical associate professor of dermatology at the New York University Langone Medical Center told that because these products do not require a prescription, people assume they are safe. But Dr. Day said anyone can be allergic to any type of product, even those available over the counter. FDA medical officer Dr. Mona Khurana recommends that before using a new product on a larger area of skin, consumers should test the product on a small area for a few days to see if they experience a reaction.

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