FDA Warns of Life-Threatening Allergic Reactions to OTC Acne Products

The FDA is warning consumers of possible life-threatening allergic reactions that may occur from using over-the-counter (OTC) acne products containing benzoyl peroxide or salicylic acid.

The FDA identifies 130 reports of adverse allergic reactions related to the treatments between 1969 to 2013. Individuals that manifested hypersensitive reactions ranged from 11 to 78 years.  Of the reactions—swelling of the face, lips, tongue, eyes, and dyspnea—42% occurred anywhere from a few minutes to a 24-hour period after initial use.
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Officials report that it is unclear if the 2 active ingredients set off the reactions or if a combination of the active and inactive ingredients was at fault.

The active ingredients are found in products such as Proactiv, Neutrogena, MaxClarity, Oxy, Aveeno, Clean & Clear, and other store brands. Consumers may check for benzoyl peroxide or salicylic acid by reading the drug facts label on OTC topical acne products including gels, face washes, lotions, solutions, cleansing pads, and toners.

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

“It’s important that consumers know about them, and that they know what to do if they occur,” she said.

-Michelle Canales

Reference:

The U.S. Food and Drug Administration. Topical acne products can cause dangerous side effects [press release]. June 25, 2014. www.fda.gov/ForConsumers/ConsumerUpdates/ucm402441.htm. Accessed June 26, 2014.