FDA: Acne Products Can Trigger Severe Allergic Reactions

In rare instances, reactions are potentially life-threatening, agency says

THURSDAY, June 26, 2014 (HealthDay News) -- Some popular over-the-counter acne treatments can cause severe irritation or even potentially life-threatening allergic reactions, the U.S. Food and Drug Administration said Wednesday. These topical products contain the active ingredients benzoyl peroxide or salicylic acid and are marketed under brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear, the FDA said.

Between 1969 and the end of January 2013, the FDA received 131 reports of serious allergic reactions to these types of acne products in people ages 11 to 78. About 42 percent of the reactions occurred within minutes to 24 hours of use, the agency said. Severe allergy symptoms such as throat tightness, shortness of breath, wheezing, low blood pressure, fainting, or collapse were experienced by patients in 40 percent of the reported cases. Other symptoms included hives; itching of the face or body; and swelling of the eyes, face, and lips.

No deaths were reported, but 44 percent of the patients required hospitalization, said the FDA. The agency said it will continue to monitor and evaluate the issue and is asking manufacturers to include label information advising consumers how to test the product's safety before they use it for the first time.

"There is currently no mention of the possibility of these very severe allergic reactions on the product labels," Mona Khurana, M.D., a medical officer at FDA, said in an agency news release. "It's important that consumers know about them, and that they know what to do if they occur."

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