FDA warns of serious allergic reactions with acne products

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration warned on Wednesday that popular acne products sold over-the-counter under brand names such as Proactiv and Neutrogena can cause rare but serious and potentially life-threatening allergic reactions.

The FDA said consumers should stop using their topical acne product and seek emergency medical help if they experience hypersensitivity reactions such as throat tightness, difficulty in breathing, feeling faint or swelling of the eyes, face, lips or tongue.

The agency said non-prescription products containing the active ingredients benzoyl peroxide or salicylic acid and marketed under brands such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno and Clean & Clear, as well as store brands, were of concern.

The agency said it has received 131 reports of such hypersensitivity reactions from consumers or manufacturers, with the majority since 2012.

The hypersensitivity reactions may occur within minutes to a day or longer after product use, the FDA said. It noted these serious allergic reaction differ from local skin irritation reactions mentioned on most of the products' labels.

"There is currently no mention of the possibility of these very severe allergic reactions on the product labels," Mona Khurana, a medical officer at FDA said in a statement.

The products are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs and other formulations.

The FDA said new users of topical acne products should use a small amount on one or two affected areas of the skin for three days to test for sensitivity reactions.

SOURCE: http://1.usa.gov/TwSCNt

FDA Drug Safety Communication, June 25, 2014.

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