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FDA Warns of Acne Medication Dangers

Filed July 1st, 2014 Eric

The U.S. Food and Drug Administration (FDA) has issued a warning that certain over-the-counter (OTC) topical acne products can cause serious and even life-threatening allergic reactions.

The FDA identified allergic reactions as “hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue.” Use of the products can also cause the development of hives.

Users of acne products containing the ingredients benzoyl peroxide and salicylic acid were advised to stop using those products right away if they experienced any of the symptoms listed above and to seek emergency medical attention, according to Refinery29.

Many of the popular name brand Acne products that are heavily commercialized were on the FDA’s list of potentially dangerous medications. “The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands,” The FDA report said. “They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.”

Dr. Doris Day, MD, MA, clinical associate professor of dermatology at New York University Langone Medical Center, said from 1969 through January 28, 2013, the FDA received 131 adverse reports from consumers and manufacturers. The agency said it was unable to completely or reliably contribute to the usage of the product alone, Refinery29 reported.

Manufacturers of OTC topical acne drug products have the option to add label directions for sensitivity testing for new users of their products, according to the FDA notice. The agency encourages new users of OTC topical acne drug products to follow these directions.

The FDA is also encouraging manufacturers to add these directions to all product labels, to reduce the risk of serious hypersensitivity reactions. “According to these directions, before using an OTC topical acne product for the first time, consumers should apply a small amount to one or two small affected areas of the skin for 3 days,” the notice said. “If no discomfort occurs, then the product can be used according to the directions on the Drug Facts label.”

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