FDA Warns Consumers About Side Effects from Topical Acne Actives

The U.S. Food and Drug Administration has issued a warning to consumers that over-the-counter (OTC) acne products containing benzoyl peroxide and salicylic acid can cause severe irritation or severe allergic reactions in rare instances.

According to the FDA, the serious allergic reactions resulting from these ingredients differ from the less harmful irritations already included in the product Drug Facts labels, which include burning, dryness, itching, peeling, redness and slight swelling where the product is applied. “There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says Mona Khurana, MD, a medical officer at FDA. “It’s important that consumers know about them, and that they know what to do if they occur.”

The FDA has issued a Drug Safety Communication (DSC) to inform both consumers and health care professionals of the potential dangers of these products. From 1969 through Jan. 28, 2013, the FDA received 131 reports from both consumers and manufacturers of allergic and hypersensitivity-related adverse reactions associated with these products. About 42% of these reactions occurred within minutes to 24 hours of use. The affected persons ranged in age from 11 to 78 years. Forty percent of these reports described severe allergy symptoms such as throat tightness, shortness of breath, wheezing, low blood pressure, fainting or collapse. Isolated instances of hives, itching of face or body (even of parts of the body where the person did not apply the medication), and swelling of eyes, face and lips were also reported.

Based on the information reported, FDA cannot determine if these reactions were triggered by the products’ active ingredients, the inactive ingredients, or a combination of both. While no deaths have been reported, 44% of the cases required hospitalization. “FDA will continue to monitor closely and evaluate this safety issue,” Khurana says.

The agency is also encouraging manufacturers to use the drug label to advise consumers how to test the product’s safety before using it for the first time. For example, Khurana suggests that new users should apply a small amount of the product to a small affected area for three days. If no discomfort occurs, they can follow the labeled directions for normal use.

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