Serious Allergic Reactions Possible With Acne Products, FDA Says

Megan Brooks

June 25, 2014

Certain over-the-counter (OTC) topical acne products can cause "rare but serious and potentially life-threatening" allergic reactions or severe irritation, the US Food and Drug Administration warned today.

The "products of concern" are marketed under various brand names such as Proactiv (Guthy-Renker), Neutrogena (Neutrogena), MaxClarity (Stiefel Laboratories, Inc), Oxy (The Mentholatum Company), Ambi (Valeant Pharmaceuticals), Aveeno (Johnson & Johnson Consumer Companies, Inc), and Clean & Clear (Johnson & Johnson Consumer Companies, Inc) and as store brands, the agency said in a statement. These products are sold as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

Healthcare professionals should advise consumers to stop using these products and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use.

"These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels," the FDA notes.

For now, the FDA says it is unclear whether the serious hypersensitivity reactions that have been reported were triggered by the acne products' active ingredients (benzoyl peroxide or salicylic acid), the inactive ingredients, or a combination of both.

The FDA says it is continuing to monitor and evaluate this safety issue and will work with manufacturers regarding any future label changes that would address the risk for severe hypersensitivity reactions.

When clinicians recommend OTC topical acne products to patients, they should alert them to potential "symptoms of serious hypersensitivity reactions such as skin or mucosal changes and, particularly, about concomitant respiratory or cardiovascular changes such as dyspnea, hypotension, or syncope suggestive of anaphylaxis," the FDA notes.

In addition, clinicians should advise patients who are using an OTC topical acne drug product for the first time "to apply a small amount to one or two small affected areas for 3 days to make sure they don't develop any hypersensitivity symptoms," the FDA says. "If no discomfort occurs, they can follow the directions on the Drug Facts label."

In January 2014, as reported by Medscape Medical News, the FDA announced it had put OTC acne products containing benzoyl peroxide, salicylic acid, or both on its latest quarterly list of products to monitor because of potential signals of hypersensitivity and anaphylactic reactions.

Healthcare professionals are encouraged to report adverse events related to the use of these products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at; with postage-paid FDA form 3500, available at; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.


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